Cleared Special

K060358 - PROFEMUR TL HIP STEM

K060358 is an FDA 510(k) clearance for PROFEMUR TL HIP STEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 3 Orthopedic device with product code KWA cleared through the Special 510(k) pathway after a 86-day FDA review.

K060358 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
86d
Days
Class 3
Risk

K060358 is an FDA 510(k) clearance for the PROFEMUR TL 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 May 10, 2006 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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: 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

FDA 510(k) Submission Details - K060358

510(k) Number K060358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2006
Decision Date May 10, 2006
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

KWA Device Classification - Class 3, Premarket Approval

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 98
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K060358.
ALTRA PRESS-FIT HIP SYSTEM
K063002 · Biomet Manufacturing Corp · Oct 2006
DUPUY S-ROM STD HIP STEM PROSTHESIS
K061221 · DePuy Orthopaedics, Inc. · Aug 2006
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
K061423 · Biomet Manufacturing Corp · Jul 2006
CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
K060356 · Wrightmedicaltechnologyinc · Apr 2006
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
K053536 · Zimmer GmbH · Mar 2006
PROFEMUR XTR HIP STEM
K052915 · Wrightmedicaltechnologyinc · Jan 2006