Cleared Traditional

K926107 - ARCOM POLYETHYLENE ACETABULAR LINERS & ...

K926107 is an FDA 510(k) clearance for ARCOM POLYETHYLENE ACETABULAR LINERS & ..., 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 237-day FDA review.

K926107 · Biomet, Inc. · Orthopedic device
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Jul 1993
Decision
237d
Days
Class 2
Risk

K926107 is an FDA 510(k) clearance for the ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS. 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 July 28, 1993 after a review of 237 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 - K926107

510(k) Number K926107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1992
Decision Date July 28, 1993
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K926107.
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K921113 · Exactech, Inc. · Oct 1993
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114 · Exactech, Inc. · Oct 1993
INFINITY POROUS-COATED TROCHANTERIC MODULE
K922159 · Wrightmedicaltechnologyinc · Oct 1993
OSTEONICS MICROSUTERED FEMORAL COMPONENTES
K926201 · Osteonics Corp. · Jun 1993
HIP JOINT PROTHESIS
K921400 · Smith & Nephew Richards, Inc. · Apr 1993
POLY-DIAL INSERTS
K924492 · Joint Medical Products Corp. · Nov 1992