Atlas FDA

KTW

38 FDA 510(k) clearances · Product code

65 daysmedian time to decision
301 days90th percentile
38clearances measured

FDA profile

Official device name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2020: 60 · 2021: 25 · 2022: 50 · 2023: 30 · 2024: 123 · 2025: 96
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PK High Tibial Osteotomy Correction System (K182285)Paonan Biotech Co., Ltd.2019-06-20
AOS Anterolateral Proximal Humeral Plate (K171606)Advanced Orthopaedic Solutions, Inc. (Aos)2017-06-22
Phantom Small Bone Intramedullary Nail System (K170693)Paragon 28, Inc.2017-06-19
AOS Anterolateral Proximal Humeral Plate (K160409)Advanced Orthopaedic Solutions, Inc.2016-03-15
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (K122541)Orthofix Srl2012-09-20
AOS PROXIMAL HUMERAL PLATE (K080590)Advanced Orthopaedic Solutions, Inc.2008-05-06
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (K080109)Synthes (Usa)2008-03-20
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (K062920)Orthofix Srl2006-11-13
LEFORTE SYSTEM BONE PLATE (K023360)Jeil Medical Corporation2002-10-25
REPROCESSED EBI EXTERNAL FIXATION DEVICES (K012645)Alliance Medical Corp.2002-06-24
REPROCESSED EXTERNAL FIXATION DEVICE (K012634)Alliance Medical, Inc.2002-06-24
SYNTHES LCP PROXIMAL HUMERUS PLATES (K011815)Synthes (Usa)2001-09-06
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM (K011458)Synthes (Usa)2001-08-02
MODULAR FOOT SYSTEM - 2.7 MM MODULE (K010321)Synthes (Usa)2001-05-02
STRYKER TRAUMA PELVIC SET (K001614)Howmedica Osteonics Corp.2000-08-04
SAMARCO SPIDER PLATES (K001271)Biomet, Inc.2000-07-14
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) (K992837)Synthes (Usa)1999-10-25
OMNI-FIX, HUMERAL NAIL (K991405)Turnkey Intergration USA, Inc.1999-06-29
OMNI-FIX, NAIL SYSTEM (K990307)Turnkey Intergration USA, Inc.1999-04-01
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) (K982390)Wrightmedicaltechnologyinc1998-09-14
TRAUMA-FIX EXTERNAL FIXATOR (K971272)Trend Medical, Inc.1997-06-05
SYNTHES CANNULATED ANGLE BLADE PLATE (K954289)Synthes (Usa)1995-11-24
MALLEOLAR SCREW (K931686)Onyx Medical Corp.1994-04-05
TORUS EXTERNAL FIXATION SYSTEM (K925635)Zimmer, Inc.1993-06-01
TRUE/FLEX METATARSAL RODS (K924657)Applied Osteo Systems, Inc.1992-11-24
ANGLED BLADE PLATE (K914546)Synthes (Usa)1991-11-29
HANSEN-STREET TYPE INTRAMEDULLARY NAIL (K905348)O'Tec Corp.1990-12-11
LEVTECH SMALL BONE PLATE (K893928)Buckman Co., Inc.1989-11-03
WARSAW ORTHOPEDIC I BONE PLATE (K870727)Warsaw Orthopedic, Inc.1987-03-09
ACROMED ADS BONE NAIL (K862552)Buckman Co., Inc.1986-09-02
EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM (K862279)Orthospec, Inc.1986-07-25
LERE NAIL & PLATE COMBIN. ONE PIECE FORGED (K851349)Medicalex1985-05-29
BONE SCREWS (K843554)Mecron Medical Products, Inc.1984-10-01
BONE PLATES (K843553)Mecron Medical Products, Inc.1984-10-01
ORTHOPEDIC FIXATION DEVICES (K821566)Howmedica Corp.1982-06-03
HIP PIN (K813340)The Deca Co.1982-01-29
SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES (K792291)Synthes (Usa)1979-12-06
COMPRESSION HIP SCREW SYSTEM (K781762)Howmedica Corp.1978-12-20

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