Cleared Special

CONSENSUS ACETABULAR SHELL SYSTEM (K060635) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060635 · Hayes Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
49d
Days
Class 2
Risk

K060635 is an FDA 510(k) clearance for the CONSENSUS ACETABULAR SHELL SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on April 28, 2006 after a review of 49 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 Hayes Medical, Inc. devices

Submission Details

510(k) Number K060635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2006
Decision Date April 28, 2006
Days to Decision 49 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K060635.
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630 · Smith & Nephew, Inc. · Jun 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581 · DePuy Orthopaedics, Inc. · May 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040 · Zimmer, Inc. · May 2006
VERSYS EPOCH FULLCOAT HIP PROSTHESIS
K052321 · Zimmer, Inc. · Feb 2006
DEPUY MODULAR M HEADS
K060031 · DePuy Orthopaedics, Inc. · Jan 2006
LINEAGE A-CLASS POLY LINER
K052026 · Wrightmedicaltechnologyinc · Dec 2005