510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910010Substantially Equivalent

Q System 28 Hip Stem

Turnkey Intergration USA, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910010 is the FDA 510(k) clearance record for Q SYSTEM 28 HIP STEM, a class II device, cleared for Turnkey Intergration USA, Inc. on under FDA product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 26 510(k) clearances for Turnkey Intergration USA, Inc., from to . As of , FDA records show no recalls naming K910010.

Clearance record

Decision date
Received
(69 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
Turnkey Intergration USA, Inc. 8021 Knue Rd., Suite 121, Indianapolis IN
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWJ, 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