Cleared Special

K013658 - MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS

K013658 is an FDA 510(k) clearance for MODIFICATION TO REFLECTION CROSS-LINKED..., 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 29-day FDA review.

K013658 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
29d
Days
Class 2
Risk

K013658 is an FDA 510(k) clearance for the MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS. 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 December 5, 2001 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.

FDA 510(k) Submission Details - K013658

510(k) Number K013658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date December 05, 2001
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.

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 K013658.
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170 · Encore Orthopedics, Inc. · Feb 2002
CEMENTED CALCAR HIP SYSTEM
K013490 · Encore Orthopedics, Inc. · Jan 2002
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · Howmedica Osteonics Corp. · Dec 2001
CONVERGE ACETABULAR SYSTEM
K012739 · Sulzer Orthopedics, Inc. · Nov 2001
AML HIP PROSTHESIS
K012364 · DePuy Orthopaedics, Inc. · Oct 2001
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
K012507 · Implex Corp. · Aug 2001
K013658 · MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
Download PDF FDA Summary Smith & Nephew, Inc.