Cleared Traditional

K003215 - MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

K003215 is an FDA 510(k) clearance for MODIFICATION OF FIXION INTRAMEDULLARY N..., manufactured by Disco-O-Tech Medical Technologies, Ltd.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K003215 · Disco-O-Tech Medical Technologies, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
75d
Days
Class 2
Risk

K003215 is an FDA 510(k) clearance for the MODIFICATION OF 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 27, 2000 after a review of 75 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.

FDA 510(k) Submission Details - K003215

510(k) Number K003215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2000
Decision Date December 27, 2000
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDS Device Classification - Class 2, Special Controls

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 K003215.
ODI TALON INTRAMEDULLARY HIP NAIL
K014189 · Orthopedic Designs, Inc. · Mar 2002
BAUMER LOCKING NAIL
K011504 · Baumer, S.A · Aug 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · Disco-O-Tech Medical Technologies, Ltd. · Dec 2000
WUJIN #3 TIBIAL NAIL
K002325 · Biologically Oriented Prostheses · Oct 2000
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · Synthes (Usa) · Oct 2000
PEDIATRIC FIXATION RODS
K000764 · Biomet, Inc. · Apr 2000
K003215 · MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
Download PDF FDA Summary Disco-O-Tech Medical …