DEPUY GCK FEMORAL AND TIBIAL COMPONENTS— 510(k) K070849

Name: FDA 510(k) clearance K070849
Creator: U.S. Food and Drug Administration
Published: 2007-06-26

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K070849 for DEPUY GCK FEMORAL AND TIBIAL COMPONENTS, Substantially Equivalent on 2007-06-26. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code NPJ
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2007-03-28
Decision date: 2007-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPJ

view all

K150307 — RESTORIS Multicompartmental Knee System2015-03-10
K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM2013-12-10
K093513 — IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM2009-12-16
K093056 — SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM2009-12-15
K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM2009-06-17

More clearances from DePuy Orthopaedics, Inc.

view all

K262130 — ATTUNE Revision Knee System2026-09-04
K252887 — DePuy ATTUNE Knee System2026-05-22
K231503 — CUPTIMIZE Advanced2023-08-22
K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
K210167 — DELTA XTEND Reverse Shoulder System2021-02-19

Adverse events under product code NPJ

product code NPJ

Injury: 258
Total: 258

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.