510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K112030Substantially Equivalent

Synthes Radial Head Prosthesis System

Synthes (USA) Products LLC, West Chester PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112030 is the FDA 510(k) clearance record for SYNTHES RADIAL HEAD PROSTHESIS SYSTEM, a class II device, cleared for Synthes USA, LLC on under FDA product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show 2 recalls naming K112030.

Clearance record

Decision date
Received
(340 days to decision)
Product code
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation
21 CFR 888.3170
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes USA, LLC 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWI

Trailing 12 months
1 clearance under product code KWI in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260