| 12 Mar 2024 | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System. | Device | Class II | 1 | Ongoing |
| 15 Feb 2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 | Device | Class II | 5 | Ongoing |
| 29 Jun 2022 | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525 | Device | Class II | 1 | Ongoing |
| 18 May 2022 | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000 | Device | Class II | 1 | Ongoing |
| 11 Mar 2022 | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | Device | Class II | 1 | Terminated |
| 5 Jan 2022 | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003 | Device | Class II | 2 | Terminated |
| 7 Dec 2021 | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | Device | Class II | 8 | Terminated |
| 9 Sep 2021 | ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001 | Device | Class II | 1 | Terminated |
| 10 Aug 2021 | TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578 | Device | Class II | 7 | Terminated |
| 1 Jul 2021 | ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080 | Device | Class II | 1 | Terminated |
| 7 May 2021 | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR | Device | Class II | 1 | Terminated |
| 22 Feb 2021 | ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or… | Device | Class II | 3 | Terminated |
| 8 Jan 2021 | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. | Device | Class II | 1 | Terminated |
| 15 Dec 2020 | Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062… | Device | Class II | 1 | Terminated |
| 3 Jan 2020 | SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block. | Device | Class II | 1 | Terminated |
| 21 Sep 2018 | CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty. | Device | Class II | 3 | Terminated |
| 18 Jul 2018 | P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 | Device | Class II | 1 | Terminated |
| 21 Jun 2018 | CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 | Device | Class II | 1 | Terminated |
| 16 Apr 2018 | ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee | Device | Class II | 2 | Terminated |
| 21 Dec 2017 | (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP… | Device | Class II | 1 | Terminated |
| 28 Nov 2017 | The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE O-1100-30-000 REV D.pdf.pdf, LE O-1100-40-000 REV D.pdf.pdf, LE O-110030100_REV D.pdf.pdf, LE O-110030110_REV D.pdf.pdf, LE O-110030120_REV D.pdf.pdf | Device | Class II | 1 | Terminated |
| 31 Aug 2017 | DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only. | Device | Class II | 2 | Terminated |
| 26 Jul 2017 | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. | Device | Class II | 2 | Terminated |
| 12 Jul 2017 | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | Device | Class II | 2 | Terminated |
| 6 Jan 2017 | DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures | Device | Class II | 1 | Terminated |
| 8 Nov 2016 | LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery | Device | Class II | 1 | Terminated |
| 25 Oct 2016 | ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU | Device | Class II | 1 | Terminated |
| 8 Jan 2016 | SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction. | Device | Class II | 1 | Terminated |
| 8 Sep 2015 | Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C. SIGMA knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is… | Device | Class II | 1 | Terminated |
| 12 Jun 2015 | ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force… | Device | Class II | 10 | Terminated |
| 4 Mar 2015 | LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery. | Device | Class II | 2 | Terminated |
| 23 Feb 2015 | RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation. | Device | Class II | 1 | Terminated |
| 11 Feb 2015 | SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical… | Device | Class II | 1 | Terminated |
| 12 Nov 2014 | I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush… | Device | Class II | 1 | Terminated |
| 10 Nov 2014 | Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial… | Device | Class II | 3 | Terminated |
| 10 Nov 2014 | The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the… | Device | Class II | 1 | Terminated |
| 7 Nov 2014 | Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. | Device | Class II | 1 | Terminated |
| 15 Oct 2014 | ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag | Device | Class II | 1 | Terminated |
| 3 Sep 2014 | RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. | Device | Class II | 1 | Terminated |
| 27 Aug 2014 | Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure. | Device | Class II | 1 | Terminated |
| 3 Jun 2014 | RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation. | Device | Class II | 3 | Terminated |
| 28 Mar 2014 | GLOBAL Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in… | Device | Class II | 1 | Terminated |
| 24 Feb 2014 | REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought… | Device | Class II | 6 | Terminated |
| 9 Dec 2013 | PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility. | Device | Class II | 1 | Terminated |
| 18 Nov 2013 | SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty. | Device | Class II | 12 | Terminated |
| 16 Sep 2013 | SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in… | Device | Class II | 1 | Terminated |
| 11 Jul 2013 | LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur. | Device | Class I | 1 | Terminated |
| 8 May 2013 | DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique. | Device | Class III | 1 | Terminated |
| 3 May 2013 | DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere. | Device | Class II | 1 | Terminated |
| 25 Feb 2013 | ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. | Device | Class II | 1 | Terminated |
| 5 Feb 2013 | Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining &… | Device | Class II | 1 | Terminated |
| 4 Jan 2013 | LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. | Device | Class I | 4 | Terminated |
| 3 Dec 2012 | SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is… | Device | Class II | 20 | Terminated |
| 28 Nov 2012 | Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE CANCELLOUS Bone Screws are ancillary fixation devices used in total hip… | Device | Class II | 1 | Terminated |
| 22 Aug 2012 | S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped.… | Device | Class II | 1 | Terminated |
| 31 Jul 2012 | DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific… | Device | Class II | 1 | Terminated |
| 24 Jul 2012 | Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second… | Device | Class II | 1 | Terminated |
| 16 May 2012 | ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink… | Device | Class II | 19 | Terminated |
| 7 Mar 2012 | Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there… | Device | Class II | 1 | Terminated |