510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K262955Substantially Equivalent

OsseoFit Stemless Shoulder System

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

Clearance record

Decision date
Received
(31 days to decision)
Product code
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer, Inc. 1800 W. Center St., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKC

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