Cleared Traditional

POROUS TITANIUM ACETABULAR SHELLS (K052996) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052996 · Biomet Manufacturing Corp · Orthopedic device
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Apr 2006
Decision
185d
Days
Class 2
Risk

K052996 is an FDA 510(k) clearance for the POROUS TITANIUM ACETABULAR SHELLS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on April 28, 2006 after a review of 185 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Manufacturing Corp devices

Submission Details

510(k) Number K052996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2005
Decision Date April 28, 2006
Days to Decision 185 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K052996.
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