Atlas FDA

JDG

59 FDA 510(k) clearances · Product code

60 daysmedian time to decision
280 days90th percentile
59clearances measured

FDA profile

Official device name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3360
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 1,206 · 2022: 886 · 2023: 289 · 2024: 300 · 2025: 265 · 2026: 143
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
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (K212431)Biomet, Inc.2022-02-07
Distal Centralizers (K193546)Biomet, Inc.2020-09-25
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (K173499)Stryker Orthopaedics2018-03-19
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (K001984)Stelkast Company2000-09-27
THE TAPER-FIT TOTAL HIP SYSTEM (K992234)Corin USA1999-11-10
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (K962002)Exactech, Inc.1996-08-08
NEXLOCK FEMORAL STEM (K955171)Nexmed, Inc.1996-02-09
LUBINUS SP II HIP SYSTEM (K953653)Turnkey Intergration USA, Inc.1995-11-06
HIP FRACTURE STEM FENESTRATION PLUG (K953067)Howmedica Corp.1995-08-21
ORTHOMET TITANIUM HYBRID FEMORAL STEM (K945783)Orthomet, Inc.1995-05-30
PROFORM CEMENTED FEMORAL COMPONENT (K951083)Stelkast Company1995-05-22
INTEGRAL CO-CR FEMORAL COMPONENT (K942479)Biomet, Inc.1994-09-20
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT (K942027)Biomet, Inc.1994-09-19
RX90 FEMORAL COMPONENT (K942028)Biomet, Inc.1994-09-19
CO-CR ANSWER FEMORAL COMPONENT (K931194)Biomet, Inc.1994-05-05
S-ROM TOTAL HIP REPLACEMENT SYSTEM (K935078)Joint Medical Products Corp.1994-03-09
BRIDGE(TM) HIP SYSTEM (K933871)Wrightmedicaltechnologyinc1994-02-23
PPC HIP STEM COMPONENT (K915385)Implantology Corp.1993-05-17
FPC HIP STEM COMPONENT (K915391)Implantology Corp.1993-04-30
UFC HIP STEM COMPONENT (K924099)Implantology Corp.1993-04-30
STABILITY HIP STEM WITH POROCOAT (K915787)Depuy, Inc.1993-04-29
AMERICANA HIP PROTHESIS (K922682)Osteo Technology, Inc.1993-03-16
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE (K911595)Dow Corning Wright1991-07-12
OPTI-FIX COLLARED FEMORAL COMPONENTS (K874868)Richards Medical Co., Inc.1988-01-26
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS (K874575)Dow Corning Wright1988-01-07
AML CALCAR FEMORAL PROSTHESIS (K874100)Depuy, Inc.1987-12-31
CTI STRAIGHT STEM (K873627)Orthopedic Systems, Inc.1987-12-30
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO (K874740)Dow Corning Wright1987-12-18
THOMPSON HIP PROSTHESIS (K874617)Orthopedic Systems, Inc.1987-12-10
HOWMEDICA PCA COLLARED FEMORAL STEM (K873458)Howmedica Corp.1987-09-23
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM (K873089)Howmedica Corp.1987-09-16
HOWMEDICA FEMORAL COMPONENT HIP SYS 6259 (K851566)Howmedica Corp.1985-07-30
BDH UNIVERSAL HIP SYSTEM SURGEON (K833468)Carbomedics, Inc.1983-12-27
BRIGHAM II TOTAL HIP SYSTEM (K812687)Hexcel Medical1981-10-02
SEATTLE II TOTAL HIP SYSTEM (K812669)Hexcel Medical1981-10-02
CHARNLEY DESIGN HIP PROSTHESIS (K801006)Colmed, Ltd.1980-05-20
HEXCEL FEMORAL COMPONENT HIP PROSTHESIS (K800051)Hexcel Medical1980-01-28
ANITOMIC TOTAL HIP SYSTEM (K800050)Hexcel Medical1980-01-24
BIOPHASE IMPLANT MATERIAL (K792329)Richard'S Medical Equip., Inc.1980-01-23
PROSTHESIS, HIP, CATHCART, SCHILLER MOD. (K780773)Depuy, Inc.1978-06-22
SPHERISTEM TOTAL HIP PROSTHESIS (K780497)American Ortomed Corp.1978-06-14
TITANIUM MULLER TOTAL HIP (K780357)Biomet, Inc.1978-04-05
TOTAL HIP, NEW ENGLAND BAPTIST (K780329)Depuy, Inc.1978-03-17
TOTAL HIP, CHARNELY TYPE (K772120)Depuy, Inc.1977-12-20
KERBOULL-CHARNLEY CUP SPECIAL MODEL (K770471)Howmedica Corp.1977-03-24
LAGRANGE LETOURNEL TOTAL HIP FEMORAL (K770473)Howmedica Corp.1977-03-17
WATSON-FARRAR TOTAL HIP REPLACEMENT (K770219)Orthopedic Equipment Co., Inc.1977-02-17
BI-CENTRIC ENDOPROSTHESES (K770184)Howmedica Corp.1977-02-08
MICROFENESTRATED HIP REPLACEMENT COMPON. (K770161)Medishield, Inc.1977-01-26
SPARBARO TYPE TOTAL HIP (K761146)Orthopedic Equipment Co., Inc.1976-12-16
12-9170 SERIES II TOTAL HIP (K761243)Richardo Manufacturing Co.1976-12-16
CHARNLEY CONGENITAL HIP FEMUR (85-3060) (K761002)Codman & Shurtleff, Inc.1976-11-23
CHARNLEY CONGENITAL HIP FEMUR (85-3061) (K761003)Codman & Shurtleff, Inc.1976-11-23
CHARNLEY REVISION SET (K760976)Codman & Shurtleff, Inc.1976-11-16
CHARNLEY FEMORAL COMPONENT (K760974)Codman & Shurtleff, Inc.1976-11-16
TOTAL HIP REPLACEMENT,LAGRANGE-LETOURNEL (K760651)Orthopedic Equipment Co., Inc.1976-10-05
PROSTHESIS, TOTAL HIP-FEMORAL (K760106)Orthopedic Equipment Co., Inc.1976-07-20
PROSTHESIS, TOTAL HIP-TEST CUP (K760108)Orthopedic Equipment Co., Inc.1976-07-20
PROSTHESIS, TOTAL HIP-TEST FEMORAL (K760107)Orthopedic Equipment Co., Inc.1976-07-20

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