510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K081620Substantially Equivalent

Modification to Depuy Delta Xtend Reverse Shoulder System

Depuy Orthopaedics Inc., Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081620 is the FDA 510(k) clearance record for MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM, a class II device, cleared for DePuy Orthopaedics, Inc. on under FDA product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented). FDA records list 209 510(k) clearances for DePuy Orthopaedics, Inc., from to . As of , FDA records show 8 recalls naming K081620.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWS

Trailing 12 months
3 clearances under product code KWS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260