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
K962224Substantially Equivalent

Select Shoulder Concentric Humeral Head Components

Intermedics Orthopedics, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962224 is the FDA 510(k) clearance record for SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS, a class II device, cleared for Intermedics Orthopedics on under FDA product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented). FDA records list 108 510(k) clearances for Intermedics Orthopedics, from to . As of , FDA records show no recalls naming K962224.

Clearance record

Decision date
Received
(79 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
Intermedics Orthopedics 9900 Spectrum Dr., Austin TX
510(k) summary
Summary
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