Nail, Fixation, Bone
FDA product code JDS · Class II (moderate risk) · 21 CFR 888.3030 · Orthopedic
53510(k) clearances
0PMA approvals
20recalls
Implantimplanted device
Manufacturers
- Smith & Nephew, Inc. 12
- Synthes (Usa) 11
- Howmedica Corp. 4
- Biomet, Inc. 3
- Disco-O-Tech Medical Technologies, Ltd. 2
- Acu Med, Inc. 1
- Narang Medical , Ltd. 1
- Aap Implantate AG 1
- Orthopedic Designs, Inc. 1
- Baumer, S.A 1
- Biologically Oriented Prostheses 1
- Howmedica Osteonics Corp. 1
- Innervision, Inc. 1
- Modular Cutting Systems, Inc. 1
- Medpac 1
- Applied Osteo Systems, Inc. 1
- De Medica Mfg., Inc. 1
- Latham Manufacturer 1
- Kirschner Medical Corp. 1
- Dow Corning Corp. Healthcare Industries Materials 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | Smith & Nephew, Inc. | 06/12/2025SE |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 09/20/2024SE |
| K241804 | TRIGEN INTERTAN 10S Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 08/22/2024SE |
| K233150 | NET BRAND Osteosynthesis Nailing SystemJDS · Traditional | Narang Medical , Ltd. | 02/20/2024SE |
| K230761 | TRIGEN META-NAIL Nail SystemJDS · Traditional | Smith & Nephew, Inc. | 06/14/2023SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | Synthes (USA) Products, LLC | 09/03/2020SE |
| K192003 | Auxein Nailing SystemJDS · Traditional | Auxein Medical Private Limited | 06/10/2020SE |
| K193533 | WIN Flexible Nail SystemJDS · Traditional | Biomet, Inc. | 02/20/2020SE |
| K141737 | Conventus PHS SystemJDS · Traditional | Conventus Orthopaedics, Inc. | 04/08/2015SE |
| K123948 | China Nails and AccessoriesJDS · Traditional | Smith & Nephew, Inc. | 03/14/2013SE |
| K111667 | Synthes Suprapatellar Insertion InstrumentsJDS · Special | Synthes (Usa) | 12/05/2011SE |
| K080706 | Connexx Locking Tibia NailJDS · Traditional | I.T.S. Implantat-Technologie-Systeme GmbH | 06/09/2008SE |
| K072095 | Synthes (USA) Pediatric LCP Hip Plate System ModificationsJDS · Traditional | Synthes (Usa) | 09/27/2007SE |
| K062872 | Synthes (USA) Pediatric LCP Hip Plate SystemJDS · Traditional | Synthes (Usa) | 03/13/2007SE |
| K061783 | Knee Fusion NailJDS · Traditional | Smith & Nephew, Inc. | 08/10/2006SE |
| K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial NailsJDS · Special | Smith & Nephew, Inc. | 06/06/2006SE |
| K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial NailsJDS · Special | Smith & Nephew, Inc. | 06/30/2005SE |
| K050938 | Knee Fusion NailJDS · Traditional | Smith & Nephew, Inc. | 05/04/2005SE |
| K040762 | Synthes (USA) Tibial Nail System ExJDS · Traditional | Synthes (Usa) | 04/12/2004SE |
| K040212 | Trigen IntertanJDS · Special | Smith & Nephew, Inc. | 02/20/2004SE |
| K033071 | Synthes (USA) Cannulated Titanium Humeral Nail SystemJDS · Traditional | Synthes (Usa) | 11/05/2003SE |
| K032634 | Normed Compression Bone Screw SystemJDS · Traditional | Noviace Corporation | 10/06/2003SE |
| K021782 | BNFJDS · Traditional | Aap Implantate AG | 08/26/2002SE |
| K014189 | Odi Talon Intramedullary Hip NailJDS · Traditional | Orthopedic Designs, Inc. | 03/21/2002SE |
| K011504 | Baumer Locking NailJDS · Traditional | Baumer, S.A | 08/14/2001SE |
| K003212 | Fixion Intramedullary Nailing System (Fixion Im Nail)JDS · Traditional | Disco-O-Tech Medical Technologies, Ltd. | 12/28/2000SE |
| K003215 | Modification of Fixion Intramedullary Nailing System (Fixion Im Nail)JDS · Traditional | Disco-O-Tech Medical Technologies, Ltd. | 12/27/2000SE |
| K002325 | Wujin #3 Tibial NailJDS · Traditional | Biologically Oriented Prostheses | 10/30/2000SE |
| K002729 | Synthes Proximal Humeral NailJDS · Traditional | Synthes (Usa) | 10/06/2000SE |
| K000764 | Pediatric Fixation RodsJDS · Special | Biomet, Inc. | 04/06/2000SE |
| K993004 | Alta Fully Threaded Cross-Locking 5.0 MM ScrewJDS · Special | Howmedica Osteonics Corp. | 10/06/1999SE |
| K992348 | Synthes Spiral Blade for Humeral Nail (SBHN)JDS · Traditional | Synthes (Usa) | 09/23/1999SE |
| K991877 | Macmed Paediatric Intramedullary NailJDS · Traditional | Innervision, Inc. | 08/06/1999SE |
| K991037 | Euclid Reduction and Guidance SystemJDS · Traditional | Modular Cutting Systems, Inc. | 06/23/1999SE |
| K983942 | Intramedullary Nail System, Locking Screw, Nail CapJDS · Abbreviated | Smith & Nephew, Inc. | 12/04/1998SE |
| K981529 | Titanium Intramedullary Nail, Titanium Locking ScrewJDS · Traditional | Smith & Nephew, Inc. | 07/09/1998SE |
| K972516 | Synthes (USA) Flexible Humeral Nail(Flex Nail) SystemJDS · Traditional | Synthes (Usa) | 09/04/1997SE |
| K962047 | Titanium Cannulated Tibial Nail (Ti CTN)JDS · Traditional | Synthes (Usa) | 07/24/1996SE |
| K943855 | Bone Fixation NailJDS · Traditional | Acu Med, Inc. | 07/12/1995SE |
| K951302 | Small Fragment Plates and ScrewsJDS · Traditional | Medpac | 05/05/1995SE |
| K940736 | Haig NailJDS · Traditional | Howmedica Corp. | 09/12/1994SE |
| K926465 | Femoral Intramedullary RodsJDS · Traditional | Applied Osteo Systems, Inc. | 08/25/1993SE |
| K924004 | Seidel Humeral Locking Nail -- Additional LengthsJDS · Traditional | Howmedica Corp. | 11/23/1992SE |
| K914453 | Universal Tibial Nail and Unreamed Tibial NailJDS · Traditional | Synthes (Usa) | 02/18/1992SE |
| K914371 | Universal Femoral NailJDS · Traditional | Synthes (Usa) | 02/18/1992SE |
| K883882 | Humeral Locking Nail SystemJDS · Traditional | Howmedica Corp. | 01/30/1989SE |
| K884406 | Tracer Hip Pinning SystemJDS · Traditional | De Medica Mfg., Inc. | 11/28/1988SE |
| K840242 | Poly Plug Cement RestrictorJDS · Traditional | Latham Manufacturer | 05/30/1984SE |
| K832328 | Intramedullary Bone PlugJDS · Traditional | Kirschner Medical Corp. | 10/20/1983SE |
| K800898 | Silastic Bone Plug H.P.(Cement Restrict)JDS · Traditional | Dow Corning Corp. Healthcare Industries Materials | 05/02/1980SE |
| K800144 | Femoral Cement RestrictorJDS · Traditional | Biomet, Inc. | 02/19/1980SE |
| K800142 | Fuson Bone Plug, RadiopaqueJDS · Traditional | Zimmer, Inc. | 02/19/1980SE |
| K770130 | B.G. Flexible Nail SystemJDS · Traditional | Howmedica Corp. | 01/26/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0229-2026 Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code:…Although the etched length on the screw is correct, the length marked on the external packaging is… | Synthes (USA) Products LLC | 09/26/2025Open, Classified |
| Z-0228-2026 Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code:…Although the etched length on the screw is correct, the length marked on the external packaging is… | Synthes (USA) Products LLC | 09/26/2025Open, Classified |
| Z-1133-2022 Class II | INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. RightRight nails were anodized, marked, and labelled as left nails and vice versa | Smith & Nephew Orthopaedics GmbH | 04/22/2022Open, Classified |
| Z-0772-2021 Class II | Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the…Manufacturing packaging error. | Smith & Nephew, Inc. | 11/02/2020Terminated |
| Z-2685-2020 Class II | TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw…A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene… | Smith & Nephew, Inc. | 06/24/2020Terminated |
| Z-0097-2018 Class II | smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET…A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down. | Smith & Nephew, Inc. | 10/24/2017Open, Classified |
| Z-1858-2017 Class II | various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory.…Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | Zimmer Biomet, Inc. | 02/17/2017Terminated |
| Z-2051-2015 Class II | TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX…A specific part and lot number was packaged and shipped prior to the completion of a required internal… | Synthes, Inc. | 06/03/2015Terminated |
| Z-2258-2014 Class II | TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith…There was an error in manufacturing which resulted in the proximal lag screw hole being positioned… | Smith & Nephew, Inc. | 07/02/2014Terminated |
| Z-1637-2014 Class II | TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF…A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Smith & Nephew Inc | 04/04/2014Terminated |
| Z-1636-2014 Class II | TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202…A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | Smith & Nephew Inc | 04/04/2014Terminated |
| Z-0404-2014 Class II | Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer…Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for… | Synthes (USA) Products LLC | 10/14/2013Terminated |
| Z-0407-2014 Class II | Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and…The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail… | Synthes USA HQ, Inc. | 07/30/2013Terminated |
| Z-0944-2013 Class II | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON…75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were… | Smith & Nephew Inc | 02/07/2013Terminated |
| Z-0943-2013 Class II | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON…75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were… | Smith & Nephew Inc | 02/07/2013Terminated |
| Z-1549-2010 | 7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium…potential compatibility issue | Synthes USA (HQ), Inc. | 02/25/2010Terminated |
| Z-1548-2010 | 7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium…potential compatibility issue | Synthes USA (HQ), Inc. | 02/25/2010Terminated |
| Z-1351-2009 | Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for…Operative Technique: further clarification and guidance is needed to help reduce the potential for distal… | Stryker Howmedica Osteonics Corp. | 03/02/2009Terminated |
| Z-1350-2009 | Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System.Operative Technique: further clarification and guidance is needed to help reduce the potential for distal… | Stryker Howmedica Osteonics Corp. | 03/02/2009Terminated |
| Z-1349-2009 | Stryker, Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture…Operative Technique: further clarification and guidance is needed to help reduce the potential for distal… | Stryker Howmedica Osteonics Corp. | 03/02/2009Terminated |