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
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K162125Substantially Equivalent

MALUC™ Total Hip Arthroplasty System

Surgtech, Inc., Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162125 is the FDA 510(k) clearance record for MALUC™ Total Hip Arthroplasty System, a class II device, cleared for Surgtech, Inc. on under FDA product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented). FDA records list 6 510(k) clearances for Surgtech, Inc., from to . As of , FDA records show no recalls naming K162125.

Clearance record

Decision date
Received
(282 days to decision)
Product code
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Applicant
Surgtech, Inc. 24600 Center Ridge Rd., Suite 195, Westlake OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDI

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