Atlas FDA

JDS

53 FDA 510(k) clearances · Product code

75 daysmedian time to decision
207 days90th percentile
53clearances measured

FDA profile

Official device name
Nail, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 630 · 2022: 589 · 2023: 358 · 2024: 466 · 2025: 505 · 2026: 200
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TRIGEN Stable Lock Nut & Washer (K243608)Smith & Nephew, Inc.2025-06-12
TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System (K240061)Smith & Nephew, Inc.2024-09-20
TRIGEN INTERTAN 10S Nail System (K241804)Smith & Nephew, Inc.2024-08-22
NET BRAND Osteosynthesis Nailing System (K233150)Narang Medical , Ltd.2024-02-20
TRIGEN META-NAIL Nail System (K230761)Smith & Nephew, Inc.2023-06-14
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm (K201336)Synthes (USA) Products, LLC2020-09-03
Auxein Nailing System (K192003)Auxein Medical Private Limited2020-06-10
WIN Flexible Nail System (K193533)Biomet, Inc.2020-02-20
CONVENTUS PHS SYSTEM (K141737)Conventus Orthopaedics, Inc.2015-04-08
CHINA NAILS AND ACCESSORIES (K123948)Smith & Nephew, Inc.2013-03-14
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667)Synthes (Usa)2011-12-05
CONNEXX LOCKING TIBIA NAIL (K080706)I.T.S. Implantat-Technologie-Systeme GmbH2008-06-09
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS (K072095)Synthes (Usa)2007-09-27
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM (K062872)Synthes (Usa)2007-03-13
KNEE FUSION NAIL (K061783)Smith & Nephew, Inc.2006-08-10
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS (K061019)Smith & Nephew, Inc.2006-06-06
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS (K051557)Smith & Nephew, Inc.2005-06-30
KNEE FUSION NAIL (K050938)Smith & Nephew, Inc.2005-05-04
SYNTHES (USA) TIBIAL NAIL SYSTEM EX (K040762)Synthes (Usa)2004-04-12
TRIGEN INTERTAN (K040212)Smith & Nephew, Inc.2004-02-20
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM (K033071)Synthes (Usa)2003-11-05
NORMED COMPRESSION BONE SCREW SYSTEM (K032634)Noviace Corporation2003-10-06
BNF (K021782)Aap Implantate AG2002-08-26
ODI TALON INTRAMEDULLARY HIP NAIL (K014189)Orthopedic Designs, Inc.2002-03-21
BAUMER LOCKING NAIL (K011504)Baumer, S.A2001-08-14
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) (K003212)Disco-O-Tech Medical Technologies, Ltd.2000-12-28
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) (K003215)Disco-O-Tech Medical Technologies, Ltd.2000-12-27
WUJIN #3 TIBIAL NAIL (K002325)Biologically Oriented Prostheses2000-10-30
SYNTHES PROXIMAL HUMERAL NAIL (K002729)Synthes (Usa)2000-10-06
PEDIATRIC FIXATION RODS (K000764)Biomet, Inc.2000-04-06
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW (K993004)Howmedica Osteonics Corp.1999-10-06
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) (K992348)Synthes (Usa)1999-09-23
MACMED PAEDIATRIC INTRAMEDULLARY NAIL (K991877)Innervision, Inc.1999-08-06
EUCLID REDUCTION AND GUIDANCE SYSTEM (K991037)Modular Cutting Systems, Inc.1999-06-23
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP (K983942)Smith & Nephew, Inc.1998-12-04
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW (K981529)Smith & Nephew, Inc.1998-07-09
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM (K972516)Synthes (Usa)1997-09-04
TITANIUM CANNULATED TIBIAL NAIL (TI CTN) (K962047)Synthes (Usa)1996-07-24
BONE FIXATION NAIL (K943855)Acu Med, Inc.1995-07-12
SMALL FRAGMENT PLATES AND SCREWS (K951302)Medpac1995-05-05
HAIG NAIL (K940736)Howmedica Corp.1994-09-12
FEMORAL INTRAMEDULLARY RODS (K926465)Applied Osteo Systems, Inc.1993-08-25
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS (K924004)Howmedica Corp.1992-11-23
UNIVERSAL FEMORAL NAIL (K914371)Synthes (Usa)1992-02-18
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL (K914453)Synthes (Usa)1992-02-18
HUMERAL LOCKING NAIL SYSTEM (K883882)Howmedica Corp.1989-01-30
TRACER HIP PINNING SYSTEM (K884406)De Medica Mfg., Inc.1988-11-28
POLY PLUG CEMENT RESTRICTOR (K840242)Latham Manufacturer1984-05-30
INTRAMEDULLARY BONE PLUG (K832328)Kirschner Medical Corp.1983-10-20
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT) (K800898)Dow Corning Corp. Healthcare Industries Materials1980-05-02
FEMORAL CEMENT RESTRICTOR (K800144)Biomet, Inc.1980-02-19
FUSON BONE PLUG, RADIOPAQUE (K800142)Zimmer, Inc.1980-02-19
B.G. FLEXIBLE NAIL SYSTEM (K770130)Howmedica Corp.1977-01-26

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Every clearance here is in the API, with alerts when new ones post.