Cleared Special

K070756 - SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM

K070756 is an FDA 510(k) clearance for SMITH AND NEPHEW REFLECTION 3 ACETABULA..., 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 78-day FDA review.

K070756 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
78d
Days
Class 2
Risk

K070756 is an FDA 510(k) clearance for the SMITH AND NEPHEW 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 June 6, 2007 after a review of 78 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 - K070756

510(k) Number K070756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2007
Decision Date June 06, 2007
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
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 K070756.
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R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · Smith & Nephew, Inc. · Nov 2009
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K061253 · Smith & Nephew, Inc. · May 2006
REFLECTION DUAL DIMENSION SHELL
K960094 · Smith & Nephew Richards, Inc. · Mar 1996
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K931107 · Arthronics, Inc. · Mar 1994
K070756 · SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.