DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS— 510(k) K032151

Name: FDA 510(k) clearance K032151
Creator: U.S. Food and Drug Administration
Published: 2003-09-26

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K032151 for DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS, Substantially Equivalent on 2003-09-26. Applicant: Depuy, Inc.. Device class: 2.

Clearance details

Applicant: Depuy, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2003-07-14
Decision date: 2003-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

view all

K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

More clearances from Depuy, Inc.

view all

K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS2005-03-14
K042664 — LPS UPPER EXTREMITY2004-12-08
K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY2004-07-22
K033959 — LPS2004-07-01
K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -0622004-05-28

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 →

Recalls naming K032151

K-number listed on FDA's recall record

Z-0412-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0413-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplastyClass II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0414-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0415-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0416-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0417-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0418-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0419-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0420-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0421-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0422-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118
Z-0423-2014 — SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.Class II·Terminated·DePuy Orthopaedics, Inc.·20131118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032151.

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