Cleared Special

K061253 - REFLECTION 3 ACETABULAR SYSTEM

K061253 is an FDA 510(k) clearance for REFLECTION 3 ACETABULAR SYSTEM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MBL cleared through the Special 510(k) pathway after a 27-day FDA review.

K061253 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
27d
Days
Class 2
Risk

K061253 is an FDA 510(k) clearance for the REFLECTION 3 ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous (product code MBL), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 27 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 - K061253

510(k) Number K061253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2006
Decision Date May 31, 2006
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

MBL Device Classification - Class 2, Special Controls

Product Code MBL Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
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 - MBL Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

All 12
Devices cleared under the same product code (MBL) and FDA review panel - the closest regulatory comparables to K061253.
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · Smith & Nephew, Inc. · Jan 2010
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · Smith & Nephew, Inc. · Nov 2009
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756 · Smith & Nephew, Inc. · Jun 2007
REFLECTION DUAL DIMENSION SHELL
K960094 · Smith & Nephew Richards, Inc. · Mar 1996
LOGYK ACETABULAR COMPONENT SYSTEM
K931107 · Arthronics, Inc. · Mar 1994
K061253 · REFLECTION 3 ACETABULAR SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.