Cleared Special

PROFEMUR TL CLASSIC HIP STEM (K123688) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K123688 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
67d
Days
Class 2
Risk

K123688 is an FDA 510(k) clearance for the PROFEMUR TL CLASSIC HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on February 8, 2013 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K123688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2012
Decision Date February 08, 2013
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 286
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K123688.
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · Wrightmedicaltechnologyinc · Jul 2013
PROFEMUR RENAISSANCE CLASSIC HIP STEM
K130984 · Wrightmedicaltechnologyinc · May 2013
PROFEMUR XM DISTAL CENTRALIZER
K130167 · Wrightmedicaltechnologyinc · Apr 2013
PROFEMUR Z CLASSIC STEMS
K123434 · Wrightmedicaltechnologyinc · Feb 2013
NOVATION CROWN CUP LINERS
K121392 · Exactech, Inc. · Jan 2013
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · Smith & Nephew, Inc. · Aug 2012