Atlas FDA

JDO

23 FDA 510(k) clearances · Product code

84 daysmedian time to decision
219 days90th percentile
23clearances measured

FDA profile

Official device name
Device, Fixation, Proximal Femoral, Implant
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2014: 15 · 2015: 19 · 2016: 44 · 2017: 26 · 2018: 18 · 2020: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OsteoCentric Integrated Hip Fastener System (K230764)OsteoCentric Technologies2023-04-18
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (K213126)Smith & Nephew, Inc.2022-09-29
OsteoCentric Integrated Hip Fastener System (K210247)Osteocentric Technologies D.B.A. Osteocentric Trauma2021-04-30
CONQUEST FN (K193029)Smith & Nephew, Inc.2020-02-28
THP Hip Fracture Plating System (K173826)Biomet, Inc.2018-02-07
CONQUEST FN (K172785)Smith & Nephew2017-12-22
CONQUEST FN (K152686)Smith & Nephew2016-03-17
TSP HIP FRACTURE PLATING SYSTEM (K140018)Biomet, Inc.2014-04-04
HIPLOC COMPRESSION HIP SCREW (K080685)Biomet Manufacturing, Inc.2008-08-15
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (K080434)Smith & Nephew, Inc.2008-04-10
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (K983814)Efratgo, Ltd. HI Tech Bio-Surgical1999-01-14
SYNTHES (USA) DHS HELIX SYSTEM (K981757)Synthes (Usa)1998-07-17
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION (K964259)Synthes (Usa)1997-01-09
VIGOR COMPRESSION HIP SCREW SYSTEM (K962644)Deutschland Surgical, Inc.1996-09-06
TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) (K953607)Synthes (Usa)1996-03-08
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] (K951904)Synthes (Usa)1995-07-17
PROFORM HIP SYSTEM (K934161)Stelkast Company1994-03-10
PROFORM HA HIP SYSTEM (K934162)Stelkast Company1994-03-09
SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT (K923613)Synthes (Usa)1993-06-22
COMPRESSION SYSTEM (K831076)Kirschner Medical Corp.1983-04-28
PROXIMAL FERMORAL HIP REPLACEMENT (K810258)Biomet, Inc.1981-03-05
BIOMET CONCENTRIC HEX SCREW (K781389)Biomet, Inc.1978-08-21
NAIL, MASSIE II (K780187)Howmedica Corp.1978-03-15

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