| 1 Jul 2026 | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm | Device | Class II | 5 | Ongoing |
| 23 Sep 2025 | BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair | Device | Class II | 1 | Ongoing |
| 9 Sep 2025 | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 | Device | Class II | 1 | Ongoing |
| 21 Oct 2024 | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 | Device | Class II | 1 | Ongoing |
| 17 May 2024 | RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206 | Device | Class II | 1 | Ongoing |
| 13 Mar 2024 | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer… | Device | Class II | 1 | Ongoing |
| 2 Nov 2023 | Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 | Device | Class II | 2 | Ongoing |
| 9 Oct 2023 | Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400 | Device | Class II | 19 | Ongoing |
| 6 Feb 2023 | G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462 | Device | Class II | 1 | Ongoing |
| 29 Dec 2022 | (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS… | Device | Class II | 2 | Ongoing |
| 15 Dec 2022 | Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341 | Device | Class II | 1 | Ongoing |
| 29 Nov 2022 | OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602 | Device | Class II | 1 | Ongoing |
| 14 Feb 2022 | BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and… | Device | Class II | 4 | Terminated |
| 7 Jan 2022 | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301 | Device | Class II | 8 | Terminated |
| 2 Jun 2021 | Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300 | Device | Class II | 17 | Terminated |
| 15 Jan 2021 | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation. | Device | Class II | 1 | Terminated |
| 23 Dec 2020 | A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone. | Device | Class II | 1 | Terminated |
| 1 Dec 2020 | Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422 | Device | Class II | 1 | Terminated |
| 25 Nov 2020 | 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones. | Device | Class II | 16 | Terminated |
| 4 Sep 2020 | Biomet Regenerex Primary Taper Cap Item Number 141269 | Device | Class II | 4 | Terminated |
| 3 Sep 2020 | (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206,… | Device | Class II | 1 | Terminated |
| 2 Sep 2020 | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere). | Device | Class II | 1 | Terminated |
| 11 May 2020 | Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300 | Device | Class II | 1 | Terminated |
| 17 Apr 2020 | Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose… | Device | Class II | 13 | Terminated |
| 13 Mar 2020 | Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy… | Device | Class II | 1 | Terminated |
| 26 Feb 2020 | BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181. | Device | Class II | 33 | Terminated |
| 25 Feb 2020 | Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589 | Device | Class II | 1 | Terminated |
| 17 Feb 2020 | Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system. | Device | Class II | 1 | Terminated |
| 28 Feb 2018 | Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction | Device | Class II | 1 | Terminated |
| 10 Jun 2016 | TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six… | Device | Class II | 1 | Terminated |
| 11 Apr 2016 | PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression. | Device | Class II | 1 | Terminated |
| 1 Apr 2016 | Various trauma and sports medicine instruments and implants. guide, surgical, instrument | Device | Class II | 14 | Terminated |
| 9 Mar 2016 | All instrumentation associated with the Prelude PF Resurfacing Knee System. | Device | Class II | 1 | Terminated |
| 16 Feb 2016 | HipLOC CHS Plate/Lag Screw Introducer | Device | Class II | 1 | Terminated |
| 16 Feb 2016 | Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly… | Device | Class II | 1 | Terminated |
| 5 Feb 2016 | Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer | Device | Class II | 1 | Terminated |
| 29 Jan 2016 | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended… | Device | Class II | 1 | Terminated |
| 2 Dec 2015 | Black Mamba Suture Passer | Device | Class II | 2 | Terminated |
| 20 Nov 2015 | A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones. | Device | Class II | 1 | Terminated |
| 17 Nov 2015 | Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm | Device | Class II | 1 | Terminated |
| 28 Jul 2015 | Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. | Device | Class II | 1 | Terminated |
| 17 Jun 2015 | A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. | Device | Class II | 1 | Terminated |
| 4 Jun 2015 | A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw | Device | Class II | 1 | Terminated |
| 4 Jun 2015 | A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. | Device | Class II | 1 | Terminated |
| 3 Jun 2015 | Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the… | Device | Class II | 1 | Terminated |
| 3 Jun 2015 | Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures. | Device | Class II | 2 | Terminated |
| 1 May 2015 | Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality | Device | Class II | 1 | Terminated |
| 22 Apr 2015 | Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. | Device | Class II | 1 | Terminated |
| 16 Apr 2015 | Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners. | Device | Class III | 4 | Terminated |
| 18 Mar 2015 | LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. | Device | Class II | 1 | Terminated |
| 26 Feb 2015 | ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or… | Device | Class II | 2 | Terminated |
| 9 Jan 2015 | Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc) | Device | Class II | 2 | Terminated |
| 7 Jan 2015 | Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400 | Device | Class II | 1 | Terminated |
| 2 Dec 2014 | Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision… | Device | Class II | 2 | Terminated |
| 26 Sep 2014 | Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only. | Device | Class II | 3 | Terminated |
| 24 Sep 2014 | Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components. | Device | Class II | 1 | Terminated |
| 17 Sep 2014 | Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. | Device | Class II | 1 | Terminated |
| 1 Jul 2014 | Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA | Device | Class II | 1 | Terminated |
| 23 Jun 2014 | Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581 | Device | Class II | 1 | Terminated |
| 15 May 2014 | DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications. | Device | Class II | 1 | Terminated |
| 7 May 2014 | G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458. | Device | Class II | 2 | Terminated |
| 22 Apr 2014 | ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant. | Device | Class II | 1 | Terminated |
| 15 Apr 2014 | EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. | Device | Class II | 3 | Terminated |
| 26 Feb 2014 | Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur. | Device | Class II | 3 | Terminated |
| 19 Dec 2013 | Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 | Device | Class II | 1 | Terminated |
| 26 Nov 2013 | G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 | Device | Class II | 1 | Terminated |
| 26 Nov 2013 | outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and… | Device | Class II | 1 | Terminated |
| 25 Oct 2013 | REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament. | Device | Class II | 1 | Terminated |
| 10 Oct 2013 | Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip. | Device | Class II | 1 | Terminated |
| 7 Jun 2013 | REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral… | Device | Class II | 30 | Terminated |
| 15 May 2013 | Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. | Device | Class II | 1 | Terminated |
| 29 Apr 2013 | Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction… | Device | Class II | 1 | Terminated |
| 26 Apr 2013 | Active Articulation E1. Intended for use with either primary or revision hip arthroplasty. | Device | Class II | 1 | Terminated |
| 5 Feb 2013 | REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument | Device | Class II | 1 | Terminated |
| 3 Jan 2013 | TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws,… | Device | Class II | 1 | Terminated |
| 15 Nov 2012 | Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications.… | Device | Class II | 1 | Terminated |
| 9 Nov 2012 | EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures. | Device | Class II | 1 | Terminated |
| 6 Nov 2012 | Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck… | Device | Class II | 1 | Terminated |
| 1 Nov 2012 | OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable. | Device | Class II | 2 | Terminated |
| 1 Nov 2012 | Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable. | Device | Class II | 1 | Terminated |
| 4 Oct 2012 | Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip… | Device | Class II | 1 | Terminated |
| 23 Aug 2012 | Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended… | Device | Class II | 2 | Terminated |
| 14 Aug 2012 | JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone. | Device | Class II | 1 | Terminated |
| 12 Dec 2006 | PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Device | Class II | 1 | Terminated |