| 25 Feb 2026 | 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. | Device | Class II | 2 | Ongoing |
| 26 Sep 2025 | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. | Device | Class II | 2 | Ongoing |
| 25 Apr 2024 | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010 | Device | Class II | 1 | Ongoing |
| 24 Jan 2024 | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S | Device | Class II | 9 | Ongoing |
| 1 Feb 2023 | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S | Device | Class II | 3 | Ongoing |
| 27 Sep 2022 | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery. | Device | Class II | 4 | Ongoing |
| 30 Aug 2022 | Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 | Device | Class II | 1 | Ongoing |
| 7 Apr 2022 | Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length. | Device | Class II | 1 | Ongoing |
| 22 Dec 2021 | Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System… | Device | Class II | 1 | Ongoing |
| 19 Nov 2020 | DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S | Device | Class II | 17 | Terminated |
| 21 Sep 2020 | DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s… | Device | Class III | 15 | Terminated |
| 21 Jul 2020 | DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381 | Device | Class II | 1 | Terminated |
| 16 Sep 2019 | Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery | Device | Class II | 1 | Terminated |
| 5 Sep 2019 | MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle | Device | Class II | 1 | Terminated |
| 12 Sep 2018 | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments. | Device | Class II | 1 | Terminated |
| 4 May 2018 | Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation. | Device | Class II | 1 | Terminated |
| 2 Apr 2018 | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 | Device | Class II | 2 | Terminated |
| 5 Mar 2018 | Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set | Device | Class II | 3 | Terminated |
| 26 Jul 2017 | 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery. | Device | Class II | 7 | Terminated |
| 21 Jul 2017 | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile | Device | Class II | 1 | Terminated |
| 31 Jan 2017 | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy | Device | Class II | 1 | Terminated |
| 29 Dec 2016 | Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head. | Device | Class II | 1 | Terminated |
| 29 Nov 2016 | Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument | Device | Class II | 1 | Terminated |
| 1 Nov 2016 | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile | Device | Class II | 1 | Terminated |
| 31 Oct 2016 | Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems. | Device | Class II | 1 | Terminated |
| 3 Oct 2016 | 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile | Device | Class II | 8 | Terminated |
| 28 Jun 2016 | Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm… | Device | Class II | 1 | Terminated |
| 7 Jun 2016 | Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850;… | Device | Class II | 1 | Terminated |
| 31 May 2016 | Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue | Device | Class II | 1 | Terminated |
| 31 May 2016 | Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant. | Device | Class II | 11 | Terminated |
| 23 May 2016 | TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects. | Device | Class II | 6 | Terminated |
| 11 May 2016 | Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. | Device | Class II | 3 | Terminated |
| 2 May 2016 | 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. | Device | Class II | 3 | Terminated |
| 2 May 2016 | DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43 | Device | Class II | 1 | Terminated |
| 2 May 2016 | LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones. | Device | Class II | 1 | Terminated |
| 18 Apr 2016 | 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing… | Device | Class II | 2 | Terminated |
| 4 Apr 2016 | 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones. | Device | Class II | 1 | Terminated |
| 23 Feb 2016 | Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla… | Device | Class II | 2 | Terminated |
| 18 Feb 2016 | Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires… | Device | Class II | 1 | Terminated |
| 16 Feb 2016 | Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument | Device | Class II | 1 | Terminated |
| 16 Feb 2016 | 6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau… | Device | Class II | 7 | Terminated |
| 6 Jan 2016 | Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879 | Device | Class II | 1 | Terminated |
| 8 Dec 2015 | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults. | Device | Class II | 5 | Terminated |
| 1 Dec 2015 | SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures. | Device | Class II | 1 | Terminated |
| 2 Nov 2015 | Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic. | Device | Class II | 1 | Terminated |
| 2 Nov 2015 | 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. | Device | Class II | 1 | Terminated |
| 19 Oct 2015 | Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. | Device | Class II | 1 | Terminated |
| 8 Oct 2015 | Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant. | Device | Class II | 1 | Terminated |
| 7 Oct 2015 | Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place… | Device | Class II | 1 | Terminated |
| 6 Oct 2015 | 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments. | Device | Class II | 1 | Terminated |
| 28 Sep 2015 | Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults… | Device | Class II | 1 | Terminated |
| 21 Sep 2015 | Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion. | Device | Class II | 1 | Terminated |
| 14 Sep 2015 | Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates | Device | Class II | 1 | Terminated |
| 4 Sep 2015 | 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal… | Device | Class II | 1 | Terminated |
| 3 Sep 2015 | Inserter for Titanium Elastic Nails (TEN), orthopedic device | Device | Class II | 1 | Terminated |
| 31 Aug 2015 | Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. | Device | Class II | 1 | Terminated |
| 11 Aug 2015 | Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions. | Device | Class II | 1 | Terminated |
| 29 Jul 2015 | VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. | Device | Class II | 1 | Terminated |
| 29 Jul 2015 | Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult… | Device | Class II | 1 | Terminated |
| 29 Jul 2015 | Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set. | Device | Class II | 1 | Terminated |
| 22 Jul 2015 | Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion | Device | Class II | 1 | Terminated |
| 1 Jul 2015 | 8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill… | Device | Class II | 1 | Terminated |
| 1 Jul 2015 | Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital. | Device | Class II | 1 | Terminated |
| 24 Jun 2015 | 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument. | Device | Class II | 1 | Terminated |
| 24 Jun 2015 | Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive… | Device | Class II | 1 | Terminated |
| 10 Jun 2015 | Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument. | Device | Class II | 1 | Terminated |
| 6 Nov 2014 | Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue. | Device | Class II | 1 | Terminated |
| 23 Oct 2014 | Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5). | Device | Class I | 1 | Terminated |
| 14 Oct 2013 | Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic… | Device | Class II | 1 | Terminated |
| 30 Jul 2013 | Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand. | Device | Class II | 1 | Terminated |
| 31 May 2013 | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. | Device | Class II | 1 | Terminated |
| 31 May 2012 | Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small… | Device | Class II | 1 | Terminated |