NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS— 510(k) K041100

Clearance details

Applicant

Zimmer, Inc.

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2004-04-27

Decision date

2004-10-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

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• 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
• K253566 — Affixus Retrograde Femoral Nailing System2026-03-12

Injury

6,545

Malfunction

2,023

Total

8,568

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-1031-2018 — CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HATCP FEM F-L MINUS CR-FLX POR HATCP FEM F-R MINUS CR-FLX POR HATCP FEM G-L MINUS CR-FLX POR HATCP FEM G-R MINUS This device is indicated for patients with severe knee pain and disabilityClass II·Terminated·Zimmer Biomet, Inc.·20171129
• Z-1032-2018 — CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This device is indicated for patients with severe knee pain and disabilityClass II·Terminated·Zimmer Biomet, Inc.·20171129
• Z-1048-2018 — CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disabilityClass II·Terminated·Zimmer Biomet, Inc.·20171129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041100.