510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123688Substantially Equivalent

Profemur Tl Classic Hip Stem

Wrightmedicaltechnologyinc, Arlington TN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123688 is the FDA 510(k) clearance record for PROFEMUR TL CLASSIC HIP STEM, a class II device, cleared for Wrightmedicaltechnologyinc on under FDA product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). FDA records list 302 510(k) clearances for Wrightmedicaltechnologyinc, from to . As of , FDA records show no recalls naming K123688.

Clearance record

Decision date
Received
(67 days to decision)
Product code
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Wrightmedicaltechnologyinc 5677 Airline Rd., Arlington TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZO

Trailing 12 months
9 clearances under product code LZO in the twelve months to November 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LZO, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20262
April 20261
May 20260
June 20261
July 20261
August 20260
September 20262
October 20261
November 20260