Cleared Traditional

PROFEMUR GLADIATOR HA HIP STEM (K112150) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K112150 · Wrightmedicaltechnologyinc · Orthopedic device
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Nov 2011
Decision
119d
Days
Class 3
Risk

K112150 is an FDA 510(k) clearance for the PROFEMUR GLADIATOR HA HIP STEM. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on November 23, 2011 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K112150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2011
Decision Date November 23, 2011
Days to Decision 119 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 57
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K112150.
DYNASTY BIOFOAM SHELL
K121544 · Wrightmedicaltechnologyinc · Jul 2012
CONSERVE THIN SHELL
K113322 · Wrightmedicaltechnologyinc · Feb 2012
PRESERVE HIP STEM
K112080 · Wrightmedicaltechnologyinc · Dec 2011
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
K113019 · Wrightmedicaltechnologyinc · Nov 2011
GLADIATOR HIP STEM
K111910 · Wrightmedicaltechnologyinc · Oct 2011
PROFEMUR(R) E CEMENTLESS HIP STEM
K111698 · Wrightmedicaltechnologyinc · Aug 2011