DEPUY SIGMA PS FEMORAL COMPONENTS— 510(k) K073529

Name: FDA 510(k) clearance K073529
Creator: U.S. Food and Drug Administration
Published: 2008-01-24

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K073529 for DEPUY SIGMA PS FEMORAL COMPONENTS, Substantially Equivalent on 2008-01-24. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2007-12-17
Decision date: 2008-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K261734 — Klassic Infection Spacer System2026-07-23
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K261032 — NovoKnee (SteriKnee)2026-04-27

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K231503 — CUPTIMIZE Advanced2023-08-22
K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
K210167 — DELTA XTEND Reverse Shoulder System2021-02-19
K203167 — DePuy Corail AMT Hip Prosthesis2020-11-19

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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 →

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