Cleared Traditional

K901456 - ORTHOSORB(R) ABSORBABLE PIN (FDA 510(k) Clearance)

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

K901456 · Johnson & Johnson International · Orthopedic device
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Aug 1990
Decision
141d
Days
Class 2
Risk

K901456 is an FDA 510(k) clearance for the ORTHOSORB(R) ABSORBABLE PIN. Classified as Pin, Fixation, Resorbable, Hard Tissue (product code OVZ), Class II - Special Controls.

Submitted by Johnson & Johnson International (Braintree, US). The FDA issued a Cleared decision on August 15, 1990 after a review of 141 days - within the typical 510(k) review window.

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: 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.

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Submission Details

510(k) Number K901456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1990
Decision Date August 15, 1990
Days to Decision 141 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 122d · This submission: 141d
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.