Cleared Traditional

K010635 - INTERLOK / HA COPELAND RESURFACING HEADS

K010635 is an FDA 510(k) clearance for INTERLOK / HA COPELAND RESURFACING HEADS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code MBF cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K010635 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
171d
Days
Class 2
Risk

K010635 is an FDA 510(k) clearance for the INTERLOK / HA COPELAND RESURFACING HEADS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (product code MBF), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 171 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3670 - 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 - K010635

510(k) Number K010635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2001
Decision Date August 20, 2001
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBF Device Classification - Class 2, Special Controls

Product Code MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3670
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 - MBF Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented

All 36
Devices cleared under the same product code (MBF) and FDA review panel - the closest regulatory comparables to K010635.
COMPREHENSIVE PRIMARY SHOULDER STEMS
K060692 · Biomet Manufacturing Corp · May 2006
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
K043100 · Biomet, Inc. · Feb 2005
BI-ANGULAR SHOULDER SYSTEM
K032895 · Biomet, Inc. · Nov 2003
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · DePuy Orthopaedics, Inc. · Jul 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · DePuy Orthopaedics, Inc. · Jun 2001
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
K844415 · Depuy, Inc. · Jan 1985