Cleared Abbreviated

K060630 - REFLECTION 3-HOLE SHELL WITH ASYMMETRIC...

K060630 is the FDA 510(k) clearance for REFLECTION 3-HOLE SHELL WITH ASYMMETRIC... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Abbreviated 510(k) pathway after a 97-day FDA review.

K060630 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
97d
Days
Class 2
Risk

K060630 is an FDA 510(k) clearance for the REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING. 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 June 14, 2006 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K060630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2006
Decision Date June 14, 2006
Days to Decision 97 days
Submission Type Abbreviated
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
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Standards-based clearance path.

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 K060630.
PCA 36MM FEMORAL HEADS
K061168 · Howmedica Osteonics Corp. · Jul 2006
DEPUY AML HIP PROSTHESIS
K061833 · DePuy Orthopaedics, Inc. · Jul 2006
DYNASTY ACETABULAR SHELL
K061547 · Wrightmedicaltechnologyinc · Jul 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581 · DePuy Orthopaedics, Inc. · May 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040 · Zimmer, Inc. · May 2006
POROUS TITANIUM ACETABULAR SHELLS
K052996 · Biomet Manufacturing Corp · Apr 2006