Cleared Special

K080625 - SMITH & NEPHEW MIS HIP STEM WITH STIKTITE

K080625 is an FDA 510(k) clearance for SMITH & NEPHEW MIS HIP STEM WITH STIKTITE, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 64-day FDA review.

K080625 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
64d
Days
Class 2
Risk

K080625 is an FDA 510(k) clearance for the SMITH & NEPHEW MIS HIP STEM WITH STIKTITE. 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 May 8, 2008 after a review of 64 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.

FDA 510(k) Submission Details - K080625

510(k) Number K080625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2008
Decision Date May 08, 2008
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

LPH Device Classification - Class 2, Special Controls

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 564
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K080625.
REVELATION HIP STEM, MODELS, 427-01, 427-02
K081679 · Encore Medical, L.P. · Aug 2008
TRITANIUM ACETABULAR SHELL SYSTEM
K081171 · Howmedica Osteonics Corp. · Jul 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · Smith & Nephew, Inc. · May 2008
APEX-LNK POLY ACETABULAR CUP LINERS
K073150 · Omni Life Science, Inc. · Feb 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · Smith & Nephew, Inc. · Jan 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
K072888 · Encore Medical, L.P. · Jan 2008
K080625 · SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
Download PDF FDA Summary Smith & Nephew, Inc.