510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K083439Substantially Equivalent

Synthes Epoca Shoulder 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)

K083439 is the FDA 510(k) clearance record for SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show no recalls naming K083439.

Clearance record

Decision date
Received
(77 days to decision)
Product code
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3670
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1301 Goshen Pkwy., West Chester PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBF

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