510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K231516Substantially Equivalent

INHANCE™ Shoulder System, Sterile Single Use Instrumentation

Depuy Ireland UC, Ringaskiddy, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231516 is the FDA 510(k) clearance record for INHANCE™ Shoulder System, Sterile Single Use Instrumentation, a class II device, cleared for Depuy Ireland UC on under FDA product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 50 510(k) clearances for Depuy Ireland UC, from to . As of , FDA records show no recalls naming K231516.

Clearance record

Decision date
Received
(57 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
Depuy Ireland UC Loughbeg, Ringaskiddy, IE
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 October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260