510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241878Substantially Equivalent

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)

Stryker Corporation (Tornier, Inc.), Bloomington MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241878 is the FDA 510(k) clearance record for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem), a class II device, cleared for Stryker Corporation (Tornier, Inc.) on under FDA product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented). FDA records list 3 510(k) clearances for Stryker Corporation (Tornier, Inc.), from to . As of , FDA records show no recalls naming K241878.

Clearance record

Decision date
Received
(161 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
Stryker Corporation (Tornier, Inc.) 10801 Nesbitt Ave. S., Bloomington MN
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