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
K002281Substantially Equivalent

Stelkast Proven Knee System

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

K002281 is the FDA 510(k) clearance record for STELKAST PROVEN KNEE SYSTEM, a class II device, cleared for Stelkast Company on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list 217 510(k) clearances for GLOBUS MEDICAL, INC., from to . As of , FDA records show one recall naming K002281.

Clearance record

Decision date
Received
(24 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Stelkast Company 800 Vinial St., Suite B-210, Pittsburgh PA
510(k) summary
Statement
Third party review
No

Clearances, product code JWH

Trailing 12 months
14 clearances under product code JWH in the twelve months to October 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20260