Cleared Special

K121221 - PROFEMUR Z REVISION HIP STEM

K121221 is an FDA 510(k) clearance for PROFEMUR Z REVISION HIP STEM, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 108-day FDA review.

K121221 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K121221

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.

LZO Device Classification - Class 2, Special Controls

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 533
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K121221.
BENCOX FORET & BENCOX DELTA
K121665 · Corentec Co., Ltd. · Sep 2012
METAFIX FEMORAL HIP STEM SIZE 1
K121439 · Corin USA · Sep 2012
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
AMISTEM AND QUADRA - LINE EXTENSION
K121011 · Medacta International · Jun 2012
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY
K120362 · Corin USA · May 2012
K121221 · PROFEMUR Z REVISION HIP STEM
Download PDF FDA Summary Wrightmedicaltechnolo…