Cleared Traditional

K140669 - G7 OSSEOTI ACETUBLAR SHELLS

K140669 is an FDA 510(k) clearance for G7 OSSEOTI ACETUBLAR SHELLS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K140669 · Biomet, Inc. · Orthopedic device
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Dec 2014
Decision
268d
Days
Class 2
Risk

K140669 is an FDA 510(k) clearance for the G7 OSSEOTI ACETUBLAR SHELLS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 11, 2014 after a review of 268 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, Inc. devices

FDA 510(k) Submission Details - K140669

510(k) Number K140669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date December 11, 2014
Days to Decision 268 days
Submission Type Traditional
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
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K140669.
EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM
K140547 · Excera Orthopedics, Inc. · Jan 2015
G7 Finned Acetabular Shell
K142746 · Biomet Manufactuting Corp. · Dec 2014
Echo Bi-Metric Microplasty Hip System
K143009 · Biomet, Inc. · Dec 2014
Restoration Anatomic Shell
K142462 · Stryker Orthopaedics · Nov 2014
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
K141676 · Renovis Surgical Technologies, Inc. · Nov 2014
ALPINE HIP STEM
K141001 · Ortho Development · Jul 2014