510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933570Substantially Equivalent for Some Indications

Resolution(tm) Hip Stem

Wrightmedicaltechnologyinc, Arlington TN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K933570 is the FDA 510(k) clearance record for RESOLUTION(TM) HIP STEM, a class I device, cleared for Wrightmedicaltechnologyinc on under FDA product code LJW (Tracheotome). FDA records list 302 510(k) clearances for Wrightmedicaltechnologyinc, from to . As of , FDA records show no recalls naming K933570.

Clearance record

Decision date
Received
(227 days to decision)
Product code
LJW Tracheotome
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Wrightmedicaltechnologyinc 5677 Airline Rd., Arlington TN
Third party review
No

Clearances, product code LJW

Trailing 12 months

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

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