DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS— 510(k) K070292

Clearance details

Applicant

Zimmer GmbH

Product code

Code KXA

Device class

Class 2

Regulation

21 CFR 888.3400

Advisory panel

Orthopedic

Date received

2007-01-31

Decision date

2007-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD2007-06-29
• K062960 — CONSERVE FEMORAL RESURFACING COMPONENT2006-12-01

• K211047 — CoCr Head2023-01-10
• K200814 — Affixus(R) Natural Nail(R) System Humeral Nail2020-04-28
• K200112 — Zimmer Hip Joint Replacement2020-04-10
• K193099 — Anatomical Shoulder System2020-01-29
• K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem2019-12-26

Injury

324

Total

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-0216-2013 — Metasul¿ Durom¿ Femoral component Sterile, RxClass II·Terminated·Zimmer, Inc.·20120904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070292.