Cleared Special

K073150 - APEX-LNK POLY ACETABULAR CUP LINERS

K073150 is an FDA 510(k) clearance for APEX-LNK POLY ACETABULAR CUP LINERS, manufactured by Omni Life Science, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 111-day FDA review.

K073150 · Omni Life Science, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
111d
Days
Class 2
Risk

K073150 is an FDA 510(k) clearance for the APEX-LNK POLY ACETABULAR CUP LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Omni Life Science, Inc. (Raynham, US). The FDA issued a Cleared decision on February 27, 2008 after a review of 111 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. 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. Standard predicate reliance. 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 - K073150

510(k) Number K073150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2007
Decision Date February 27, 2008
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 564
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K073150.
TRITANIUM ACETABULAR SHELL SYSTEM
K081171 · Howmedica Osteonics Corp. · Jul 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · Smith & Nephew, Inc. · May 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · Smith & Nephew, Inc. · May 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · Smith & Nephew, Inc. · Jan 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
K072888 · Encore Medical, L.P. · Jan 2008
ACCIN HIP SYSTEM
K073068 · Accelerated Innovation, LLC · Jan 2008
K073150 · APEX-LNK POLY ACETABULAR CUP LINERS
Download PDF FDA Summary Omni Life Science, In…