Cleared Special

K102423 - DEPUY PINNACLE ALTRX ACETABULAR LINERS

K102423 is an FDA 510(k) clearance for DEPUY PINNACLE ALTRX ACETABULAR LINERS, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 65-day FDA review.

K102423 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
65d
Days
Class 2
Risk

K102423 is an FDA 510(k) clearance for the DEPUY PINNACLE ALTRX ACETABULAR LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 65 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 - K102423

510(k) Number K102423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2010
Decision Date October 29, 2010
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

LPH Device Classification - Class 2, Special Controls

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 560
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K102423.
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K101976 · Omni Life Science, Inc. · Sep 2010