SYNTHES RADIAL HEAD PROSTHESIS SYSTEM— 510(k) K112030

Clearance details

Applicant

Synthes USA, LLC

Product code

Code KWI

Device class

Class 2

Regulation

21 CFR 888.3170

Advisory panel

Orthopedic

Date received

2011-07-15

Decision date

2012-06-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, US

• K260624 — Arthrex Radial Head Replacement System2026-07-30
• K233592 — BioPoly Radial Head Implant2024-03-13
• K231188 — ALIGN Radial Head System2023-09-28
• K213563 — DePuy Synthes Radial Head Replacement System2022-03-18
• K212872 — Avenger Radial Head System2021-12-17

• K180821 — TruMatch Graft Cage - Long Bone2018-12-21
• K161417 — DePuy Synthes MAXFRAME Multi-Axial Correction System2016-11-10
• K152239 — Zero-P Natural Plate System2015-12-02
• K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM2013-05-20
• K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR2012-05-25

Injury

490

Total

490

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-1124-2017 — Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.Class II·Terminated·Synthes (USA) Products LLC·20161229
• Z-1238-2013 — Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.Class II·Terminated·Synthes USA HQ, Inc.·20130222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112030.