510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934161Substantially Equivalent

Proform Hip System

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

K934161 is the FDA 510(k) clearance record for PROFORM HIP SYSTEM, a class II device, cleared for Stelkast Company on under FDA product code JDO (Device, Fixation, Proximal Femoral, Implant). FDA records list 217 510(k) clearances for GLOBUS MEDICAL, INC., from to . As of , FDA records show no recalls naming K934161.

Clearance record

Decision date
Received
(195 days to decision)
Product code
JDO Device, Fixation, Proximal Femoral, Implant
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Stelkast Company 800 Vinial St., Suite B-210, Pittsburgh PA
510(k) summary
Summary
Third party review
No

Clearances, product code JDO

Trailing 12 months
1 clearance under product code JDO in the twelve months to November 2026, October 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260