SMALL BONE LOCKING PLATING SYSTEM— 510(k) K081546

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2008-06-02

Decision date

2008-08-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
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• K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
• K261511 — Xpert Ankle2026-07-28
• K261406 — Versalock Proximal Tibial Plating System2026-07-21

• K252887 — DePuy ATTUNE Knee System2026-05-22
• K231503 — CUPTIMIZE Advanced2023-08-22
• K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
• K210167 — DELTA XTEND Reverse Shoulder System2021-02-19
• K203167 — DePuy Corail AMT Hip Prosthesis2020-11-19

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-2965-2018 — Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.Class II·Terminated·Zimmer Biomet, Inc.·20180712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081546.