Cleared Special

K024134 - UNI HIP STEM

K024134 is an FDA 510(k) clearance for UNI HIP STEM, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K024134 · Plus Orthopedics · Orthopedic device
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Jan 2003
Decision
30d
Days
Class 2
Risk

K024134 is an FDA 510(k) clearance for the UNI HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Plus Orthopedics (Round Rock, US). The FDA issued a Cleared decision on January 15, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Plus Orthopedics devices

FDA 510(k) Submission Details - K024134

510(k) Number K024134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date January 15, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 62
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K024134.
MODIFICATION TO MODULAR PLUS REVISION STEM
K030971 · Plus Orthopedics · Apr 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · Howmedica Osteonics Corp. · Mar 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · DePuy Orthopaedics, Inc. · Feb 2003
PROXILOCK HIP PROSTHESIS
K022966 · Implex Corp. · Oct 2002
TRI-FIT FEMORAL STEM
K010243 · Corin USA · Feb 2001
PRO-FEMUR R
K003016 · Wrightmedicaltechnologyinc · Dec 2000