NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS— 510(k) K043101

Clearance details

Applicant

Zimmer, Inc.

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2004-11-09

Decision date

2005-03-07

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

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• K262130 — ATTUNE Revision Knee System2026-09-04
• K253961 — SK Knee System2026-09-01

• K260831 — Z1 Hip System2026-06-16
• K261683 — Augment Off-Axis Instrument System2026-06-16
• K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
• K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
• K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)2026-04-13

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 →

• Z-1148-2016 — Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR 595004701 NEXGEN MIS TIBIA PLATE PR 595004702 NEXGEN MIS TIBIA PLATE PR 595005701 NEXGEN MIS TIBIA PLATE PR 595005702 NEXGEN MIS TIBIA PLATE PR for use in total knee arthroplastyClass II·Terminated·Zimmer Manufacturing B.V.·20160111
• Z-1931-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1932-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1933-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1934-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1935-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1936-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1937-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1938-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1939-2014 — NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.Class II·Terminated·Zimmer, Inc.·20140519
• Z-1023-2014 — MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LIClass II·Terminated·Zimmer, Inc.·20131011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043101.