Cleared Traditional

2.0/2.4 CANNULATED SCREW SYSTEM (K010783) - FDA 510(k) Clearance

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

K010783 · Osteomed Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2001
Decision
76d
Days
Class 2
Risk

K010783 is an FDA 510(k) clearance for the 2.0/2.4 CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on May 30, 2001 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Osteomed Corp. devices

Submission Details

510(k) Number K010783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2001
Decision Date May 30, 2001
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 HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K010783.
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa) · Dec 2001
INTEX SCREW
K012798 · Biomet, Inc. · Nov 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · Aesculap, Inc. · Aug 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc. · May 2001
LACTOSORB 5.0 MM WASHER
K001581 · Biomet, Inc. · Mar 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
K003816 · Arthrex, Inc. · Mar 2001