510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K010243Substantially Equivalent

Tri-Fit Femoral Stem

Corin USA, Tampa FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010243 is the FDA 510(k) clearance record for TRI-FIT FEMORAL STEM, a class II device, cleared for Corin USA on under FDA product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 78 510(k) clearances for Corin USA, from to . As of , FDA records show no recalls naming K010243.

Clearance record

Decision date
Received
(21 days to decision)
Product code
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Corin USA 10500 University Center Dr., Tampa FL
510(k) summary
Summary
Third party review
No

Clearances, product code LWJ

Trailing 12 months

FDA records hold no clearances under product code LWJ in the trailing twelve months.

FDA records show no clearances under product code LWJ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260