Cleared Traditional

K140625 - ORTHOSORB LS (FDA 510(k) Clearance)

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

K140625 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2014
Decision
38d
Days
Class 2
Risk

K140625 is an FDA 510(k) clearance for the ORTHOSORB LS. Classified as Pin, Fixation, Resorbable, Hard Tissue (product code OVZ), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 18, 2014 after a review of 38 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, Inc. devices

Submission Details

510(k) Number K140625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2014
Decision Date April 18, 2014
Days to Decision 38 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
84d faster than avg
Panel avg: 122d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVZ Pin, Fixation, Resorbable, Hard Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
Definition Intended For Small Bone Fixation In Fracture, Osteotomy, And Arthrodesis Applications.
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.