Cleared Special

PROFEMUR Z REVISION HIP STEM (K121221) - FDA 510(k) Clearance

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

K121221 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 2012
Decision
108d
Days
Class 2
Risk

K121221 is an FDA 510(k) clearance for the PROFEMUR Z REVISION 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 August 9, 2012 after a review of 108 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K121221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2012
Decision Date August 09, 2012
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
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 K121221.
PROFEMUR Z CLASSIC STEMS
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K121392 · Exactech, Inc. · Jan 2013
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · Smith & Nephew, Inc. · Aug 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211 · Smith & Nephew, Inc. · Jul 2012
TAPER OXINIUM FEMORAL HEAD
K110101 · Smith & Nephew, Inc. · Apr 2011
DEPUY CORAIL HIP SYSTEM, REVISION STEM
K093736 · DePuy Orthopaedics, Inc. · Mar 2011