Cleared Traditional

K010635 - INTERLOK / HA COPELAND RESURFACING HEADS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010635 · Biomet, Inc. · Orthopedic device
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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

Submission Details

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
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.

Device Classification

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.
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
K253592 · Zimmer, Inc. · Apr 2026
Identity Revision Humeral Stems
K251098 · Zimmer, Inc. · Aug 2025
Identity Shoulder System
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Identity Shoulder System
K240876 · Zimmer, Inc. · Jun 2024
PRIMA Humeral System
K233712 · Lima Corporate S.P.A. · Jan 2024
SMR Hybrid Glenoid System
K231099 · Lima Corporate S.P.A. · Dec 2023