510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K994041Substantially Equivalent

Tornier Bipolar Radial Head Prosthesis

TORNIER Inc., Pleasant Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994041 is the FDA 510(k) clearance record for TORNIER BIPOLAR RADIAL HEAD PROSTHESIS, a class II device, cleared for Tornier, Inc. on under FDA product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer). FDA records list 140 510(k) clearances for Tornier, Inc., from to . As of , FDA records show no recalls naming K994041.

Clearance record

Decision date
Received
(276 days to decision)
Product code
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Regulation
21 CFR 888.3170
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier, Inc. 200 Gregory Ln. Suite C-100, Pleasant Hill CA
510(k) summary
Summary
Third party review
No

Clearances, product code KWI

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