Cleared Traditional

K101063 - SLEEVE WITH ZIPLOOP FIXATION DEVICES

K101063 is the FDA 510(k) clearance for SLEEVE WITH ZIPLOOP FIXATION DEVICES by Biomet Sports Medicine. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K101063 · Biomet Sports Medicine · Orthopedic device
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Jun 2010
Decision
68d
Days
Class 2
Risk

K101063 is an FDA 510(k) clearance for the SLEEVE WITH ZIPLOOP FIXATION DEVICES. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Biomet Sports Medicine (Warsaw, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Sports Medicine devices

Submission Details

510(k) Number K101063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2010
Decision Date June 23, 2010
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
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