NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL LOCKING SYSTEM, 3.5MM TIVANIUM TI-6AL-4V— 510(k) K081759

Clearance details

Applicant

Zimmer GmbH

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2008-06-20

Decision date

2008-10-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
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• K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
• K261511 — Xpert Ankle2026-07-28

• 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

Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

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-0332-2020 — NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107Class II·Terminated·Zimmer Biomet, Inc.·20191010
• Z-0246-2013 — NCB¿-PH PlateClass II·Terminated·Zimmer, Inc.·20120904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081759.