Cleared Special

K122296 - SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING

K122296 is an FDA 510(k) clearance for SL-PLUS MIA FEMORAL STEMS WITH TI/HA CO..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K122296

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.

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 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
K122296 · SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
Download PDF FDA Summary Smith & Nephew, Inc.