Atlas FDA

OQG

20 FDA 510(k) clearances · Product code

144 daysmedian time to decision
414 days90th percentile
20clearances measured

FDA profile

Official device name
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3358
Medical specialty
Orthopedic
Flags
Implant
FDA definition
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Adverse events (MAUDE)
2020: 178 · 2021: 88 · 2022: 32 · 2023: 18 · 2024: 20 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Prime and DYNASTY® Additive Manufacturing Shells (K202705)Microport Orthopedics, Inc.2021-08-20
KMTI Hip Replacement System (K203472)Kyocera Medical Technologies, Inc.2021-04-02
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (K201660)Kyocera Medical Technologies, Inc.2020-07-16
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (K200328)Kyocera Medical Technologies, Inc.2020-03-11
FMP Extended Liners (K172651)Encore Medical L.P.2017-12-13
Renovis Surgical Hip Replacement System (K171543)Renovis Surgical Technologies2017-11-16
Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly (K173104)Total Joint Orthopedics, Inc.2017-10-27
Renovis Surgical Hip Replacement System (K143647)Renovis Surgical Technologies, Inc.2015-05-11
X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED (K140130)Encore Medical L.P.2014-11-06
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY (K141972)Total Joint Orthopedics, Inc.2014-10-09
NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG (K140701)Novosource, Inc.2014-06-27
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT (K130652)Consensus Orthopedics, Inc.2013-12-17
PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (K122783)Aesculap Implant System, Inc.2013-10-30
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER (K130365)Encore Medical L.P.2013-09-23
PBP TOTAL HIP SYSTEM (K122158)Pipeline Biomedical Products, LLC2012-12-11
CROSS-OVER ACETABULAR SHELL & LINER (K122773)Stelkast Company2012-10-09
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS (K112897)Renovis Surgical Technologies, LLC2012-06-13
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS (K120370)Zimmer, Inc.2012-06-04
PIPELINE TOTAL HIP SYSTEM (K112802)Pipeline Orthopedics2012-03-09
EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM (K094035)Stelkast Company2011-03-24

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