DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)— 510(k) K061648

Name: FDA 510(k) clearance K061648
Creator: U.S. Food and Drug Administration
Published: 2006-09-11

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K061648 for DEPUY GRADUATED COMPARTMENTAL KNEE (GCK), Substantially Equivalent on 2006-09-11. 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: 2006-06-13
Decision date: 2006-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPJ

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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.

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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 →

Recalls naming K061648

K-number listed on FDA's recall record

Z-1219-2018 — (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706Class II·Terminated·DePuy Orthopaedics, Inc.·20171221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061648.

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