Cleared Special

K022902 - SMITH & NEPHEW HIP SYSTEM

K022902 is the FDA 510(k) clearance for SMITH & NEPHEW HIP SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 29-day FDA review.

K022902 · Smith & Nephew, Inc. · Orthopedic device
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Oct 2002
Decision
29d
Days
Class 2
Risk

K022902 is an FDA 510(k) clearance for the SMITH & NEPHEW HIP SYSTEM. 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 2, 2002 after a review of 29 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 K022902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date October 02, 2002
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 442
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K022902.
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079 · Zimmer, Inc. · Feb 2003
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409 · Biomet, Inc. · Nov 2002
ARCPM 1050 RESIN-HIPS
K023357 · Biomet Orthopedics, Inc. · Nov 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · Zimmer, Inc. · Sep 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · Smith & Nephew, Inc. · Aug 2002
HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
K022463 · Biomet Orthopedics, Inc. · Aug 2002