DEPUY CORAIL AMT HIP PROSTHESIS— 510(k) K123991

Name: FDA 510(k) clearance K123991
Creator: U.S. Food and Drug Administration
Published: 2013-09-16

Substantially Equivalent

Depuy France S.A.S.

FDA 510(k) clearance K123991 for DEPUY CORAIL AMT HIP PROSTHESIS, Substantially Equivalent on 2013-09-16. Applicant: Depuy France S.A.S.. Device class: 2.

Clearance details

Applicant: Depuy France S.A.S.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 2012-12-26
Decision date: 2013-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K253357 — b-ONE® Bipolar Head2026-04-13
K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)2025-08-25
K231526 — CORAIL Cemented Femoral Stem2023-12-19
K223441 — SpaceFlex Acetabular Cup2023-03-23
K221794 — Vario-Cup System2022-07-20

More clearances from Depuy France S.A.S.

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K173960 — DePuy Corail AMT Hip Prosthesis2018-09-21

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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 K123991

K-number listed on FDA's recall record

Z-2521-2018 — CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511Class II·Terminated·DePuy Orthopaedics, Inc.·20180621

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123991.

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