Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDS — Predicate Candidate Screening
53 FDA 510(k) clearances under this product code; the 50 most recent screened below.
75 daysmedian FDA review time
207 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025-06-12 | 202 | 0 |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nai | Smith & Nephew, Inc. | 2024-09-20 | 255 | 0 |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | 2024-08-22 | 62 | 0 |
| K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical , Ltd. | 2024-02-20 | 146 | 0 |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | 2023-06-14 | 86 | 0 |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Sc | Synthes (USA) Products, LLC | 2020-09-03 | 106 | 2 |
| K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020-06-10 | 320 | 0 |
| K193533 | WIN Flexible Nail System | Biomet, Inc. | 2020-02-20 | 62 | 0 |
| K141737 | CONVENTUS PHS SYSTEM | Conventus Orthopaedics, Inc. | 2015-04-08 | 285 | 0 |
| K123948 | CHINA NAILS AND ACCESSORIES | Smith & Nephew, Inc. | 2013-03-14 | 83 | 0 |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | Synthes (Usa) | 2011-12-05 | 174 | 1 |
| K080706 | CONNEXX LOCKING TIBIA NAIL | I.T.S. Implantat-Technologie-Systeme GmbH | 2008-06-09 | 89 | 0 |
| K072095 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | Synthes (Usa) | 2007-09-27 | 58 | 0 |
| K062872 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM | Synthes (Usa) | 2007-03-13 | 168 | 0 |
| K061783 | KNEE FUSION NAIL | Smith & Nephew, Inc. | 2006-08-10 | 45 | 0 |
| K061019 | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS | Smith & Nephew, Inc. | 2006-06-06 | 54 | 0 |
| K051557 | TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS | Smith & Nephew, Inc. | 2005-06-30 | 17 | 0 |
| K050938 | KNEE FUSION NAIL | Smith & Nephew, Inc. | 2005-05-04 | 20 | 0 |
| K040762 | SYNTHES (USA) TIBIAL NAIL SYSTEM EX | Synthes (Usa) | 2004-04-12 | 18 | 2 |
| K040212 | TRIGEN INTERTAN | Smith & Nephew, Inc. | 2004-02-20 | 21 | 3 |
| K033071 | SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM | Synthes (Usa) | 2003-11-05 | 37 | 2 |
| K032634 | NORMED COMPRESSION BONE SCREW SYSTEM | Noviace Corporation | 2003-10-06 | 41 | 0 |
| K021782 | BNF | Aap Implantate AG | 2002-08-26 | 88 | 0 |
| K014189 | ODI TALON INTRAMEDULLARY HIP NAIL | Orthopedic Designs, Inc. | 2002-03-21 | 90 | 0 |
| K011504 | BAUMER LOCKING NAIL | Baumer, S.A | 2001-08-14 | 90 | 0 |
| K003212 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-28 | 76 | 0 |
| K003215 | MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION | Disco-O-Tech Medical Technologies, Ltd. | 2000-12-27 | 75 | 0 |
| K002325 | WUJIN #3 TIBIAL NAIL | Biologically Oriented Prostheses | 2000-10-30 | 90 | 0 |
| K002729 | SYNTHES PROXIMAL HUMERAL NAIL | Synthes (Usa) | 2000-10-06 | 35 | 0 |
| K000764 | PEDIATRIC FIXATION RODS | Biomet, Inc. | 2000-04-06 | 28 | 0 |
| K993004 | ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW | Howmedica Osteonics Corp. | 1999-10-06 | 29 | 0 |
| K992348 | SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) | Synthes (Usa) | 1999-09-23 | 71 | 2 |
| K991877 | MACMED PAEDIATRIC INTRAMEDULLARY NAIL | Innervision, Inc. | 1999-08-06 | 65 | 0 |
| K991037 | EUCLID REDUCTION AND GUIDANCE SYSTEM | Modular Cutting Systems, Inc. | 1999-06-23 | 86 | 0 |
| K983942 | INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP | Smith & Nephew, Inc. | 1998-12-04 | 29 | 0 |
| K981529 | TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW | Smith & Nephew, Inc. | 1998-07-09 | 71 | 2 |
| K972516 | SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM | Synthes (Usa) | 1997-09-04 | 59 | 0 |
| K962047 | TITANIUM CANNULATED TIBIAL NAIL (TI CTN) | Synthes (Usa) | 1996-07-24 | 57 | 0 |
| K943855 | BONE FIXATION NAIL | Acu Med, Inc. | 1995-07-12 | 338 | 0 |
| K951302 | SMALL FRAGMENT PLATES AND SCREWS | Medpac | 1995-05-05 | 44 | 1 |
| K940736 | HAIG NAIL | Howmedica Corp. | 1994-09-12 | 207 | 0 |
| K926465 | FEMORAL INTRAMEDULLARY RODS | Applied Osteo Systems, Inc. | 1993-08-25 | 244 | 0 |
| K924004 | SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS | Howmedica Corp. | 1992-11-23 | 105 | 0 |
| K914371 | UNIVERSAL FEMORAL NAIL | Synthes (Usa) | 1992-02-18 | 140 | 0 |
| K914453 | UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL | Synthes (Usa) | 1992-02-18 | 137 | 0 |
| K883882 | HUMERAL LOCKING NAIL SYSTEM | Howmedica Corp. | 1989-01-30 | 139 | 0 |
| K884406 | TRACER HIP PINNING SYSTEM | De Medica Mfg., Inc. | 1988-11-28 | 40 | 0 |
| K840242 | POLY PLUG CEMENT RESTRICTOR | Latham Manufacturer | 1984-05-30 | 131 | 0 |
| K832328 | INTRAMEDULLARY BONE PLUG | Kirschner Medical Corp. | 1983-10-20 | 97 | 0 |
| K800898 | SILASTIC BONE PLUG H.P.(CEMENT RESTRICT) | Dow Corning Corp. Healthcare Industries Materials | 1980-05-02 | 14 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda