BIOMET MODULAR FEMORAL REVISION SYSTEM— 510(k) K090757

Name: FDA 510(k) clearance K090757
Creator: U.S. Food and Drug Administration
Published: 2009-09-25

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K090757 for BIOMET MODULAR FEMORAL REVISION SYSTEM, Substantially Equivalent on 2009-09-25. Applicant: Biomet, Inc.. Device class: 3.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 2009-03-23
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWA

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K122778 — PROFEMUR Z REVISION HIP STEM2012-10-11
K121544 — DYNASTY BIOFOAM SHELL2012-07-30
K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28

More clearances from Biomet, Inc.

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K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K090757

K-number listed on FDA's recall record

Z-2259-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300Class II·Terminated·Biomet, Inc.·20210602
Z-2260-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301Class II·Terminated·Biomet, Inc.·20210602
Z-2261-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302Class II·Terminated·Biomet, Inc.·20210602
Z-2262-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310Class II·Terminated·Biomet, Inc.·20210602
Z-2263-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311Class II·Terminated·Biomet, Inc.·20210602
Z-2264-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312Class II·Terminated·Biomet, Inc.·20210602
Z-2265-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314Class II·Terminated·Biomet, Inc.·20210602
Z-2266-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315Class II·Terminated·Biomet, Inc.·20210602
Z-2267-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321Class II·Terminated·Biomet, Inc.·20210602
Z-2268-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322Class II·Terminated·Biomet, Inc.·20210602
Z-2269-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325Class II·Terminated·Biomet, Inc.·20210602
Z-2270-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331Class II·Terminated·Biomet, Inc.·20210602
Z-2271-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333Class II·Terminated·Biomet, Inc.·20210602
Z-2272-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335Class II·Terminated·Biomet, Inc.·20210602
Z-2273-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342Class II·Terminated·Biomet, Inc.·20210602
Z-2274-2021 — Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343Class II·Terminated·Biomet, Inc.·20210602
Z-2275-2021 — Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354Class II·Terminated·Biomet, Inc.·20210602
Z-2820-2018 — ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.Class II·Terminated·Zimmer Biomet, Inc.·20180608

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090757.

Data sourced from openFDA. This site is unofficial and independent of the FDA.