Cleared Special

K122296 - SL-PLUS MIA FEMORAL STEMS WITH TI/HA CO...

K122296 is the FDA 510(k) clearance for SL-PLUS MIA FEMORAL STEMS WITH TI/HA CO... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 28-day FDA review.

K122296 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
28d
Days
Class 2
Risk

K122296 is an FDA 510(k) clearance for the SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 28 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K122296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2012
Decision Date August 28, 2012
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 427
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K122296.
MPACT EXTENSION
K122641 · Medacta International · Sep 2012
BENCOX FORET & BENCOX DELTA
K121665 · Corentec Co., Ltd. · Sep 2012
METAFIX FEMORAL HIP STEM SIZE 1
K121439 · Corin USA · Sep 2012
PROFEMUR Z REVISION HIP STEM
K121221 · Wrightmedicaltechnologyinc · 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