Cleared Traditional

K003212 - FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) (FDA 510(k) Clearance)

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

K003212 · Disco-O-Tech Medical Technologies, Ltd. · Orthopedic device
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Dec 2000
Decision
76d
Days
Class 2
Risk

K003212 is an FDA 510(k) clearance for the FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL). Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Disco-O-Tech Medical Technologies, Ltd. (Washington, D.C., US). The FDA issued a Cleared decision on December 28, 2000 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Disco-O-Tech Medical Technologies, Ltd. devices

Submission Details

510(k) Number K003212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2000
Decision Date December 28, 2000
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K003212.
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