Cleared Traditional

K162125 - MALUC Total Hip Arthroplasty System

K162125 is the FDA 510(k) clearance for MALUC Total Hip Arthroplasty System by Surgtech, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K162125 · Surgtech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
282d
Days
Class 2
Risk

K162125 is an FDA 510(k) clearance for the MALUC™ Total Hip Arthroplasty System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Surgtech, Inc. (Westlake, US). The FDA issued a Cleared decision on May 10, 2017 after a review of 282 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgtech, Inc. devices

Submission Details

510(k) Number K162125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date May 10, 2017
Days to Decision 282 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 122d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 436
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K162125.
EXETER Centralizer, EXETER 2.5mm Plug
K191414 · Stryker Orthopaedics · Aug 2019
Cemented TSI Hip Stem
K181340 · Signature Orthopaedics Pty, Ltd. · Feb 2019
Libertas Hip Replacement System
K180973 · Maxx Orthopedics, Inc. · Sep 2018
REDAPT Anteverted Cemented Liner
K160923 · Smith & Nephew, Inc. · Nov 2016
OSS/Arcos IM Total Femur Rod
K152621 · Biomet, Inc. · Oct 2015
Corin TaperFit Hip Stem
K142761 · Corin USA · Apr 2015