Cleared Traditional

K061498 - ALLOFIX ANCHOR, 5.0 MM ANCHOR (FDA 510(k) Clearance)

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

K061498 · Musculoskeletal Transplant Foundation · Orthopedic device
Jul 2006
Decision
36d
Days
Class 2
Risk

K061498 is an FDA 510(k) clearance for the ALLOFIX ANCHOR, 5.0 MM ANCHOR. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on July 6, 2006 after a review of 36 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.

Submission Details

510(k) Number K061498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2006
Decision Date July 06, 2006
Days to Decision 36 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 116d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K061498.
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