NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES— 510(k) K061211

Clearance details

Applicant

Zimmer GmbH

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2006-05-01

Decision date

2006-06-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
• K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
• K262537 — Versalock Sterile Plating System2026-08-19
• 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-0303-2020 — NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos. 0202261205 0202261207 0202261209 0202261213 0202261305 0202261307 0202261309 0202261313Class II·Terminated·Zimmer Biomet, Inc.·20191010
• Z-0243-2013 — NCB¿ cancellous screwClass II·Terminated·Zimmer, Inc.·20120904
• Z-0244-2013 — NCB¿ screw ¿ 4.0 self-tappingClass II·Terminated·Zimmer, Inc.·20120904
• Z-0245-2013 — NCB¿-PT lateral proximal 3 hole tibial 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 K061211.