Cleared Special

K123012 - SMITH & NEPHEW SMF HIP STEM

K123012 is the FDA 510(k) clearance for SMITH & NEPHEW SMF HIP STEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 26-day FDA review.

K123012 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
26d
Days
Class 2
Risk

K123012 is an FDA 510(k) clearance for the SMITH & NEPHEW SMF HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 24, 2012 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K123012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date October 24, 2012
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 441
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K123012.
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
K121297 · Signature Orthopaedics Pty, Ltd. · Dec 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898 · Lima Corporate S.P.A. · Dec 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636 · Encore Medical, L.P. · Nov 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019 · Zimmer, Inc. · Oct 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
K122798 · Exactech, Inc. · Oct 2012
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
K122504 · United Orthopedic Corporation · Oct 2012