510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953268Substantially Equivalent

Dual Taper Wedge Pressed Fit Femoral Component

Globus Medical, Inc., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953268 is the FDA 510(k) clearance record for DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT, a class II device, cleared for Stelkast Company on under FDA product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 217 510(k) clearances for GLOBUS MEDICAL, INC., from to . As of , FDA records show 2 recalls naming K953268.

Clearance record

Decision date
Received
(188 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
Stelkast Company 800 Vinial St. #210, Pittsburgh PA
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 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