Cleared Traditional

CANCELLOUS BONE SCREW (K864626) - FDA 510(k) Clearance

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

K864626 · Dow Corning Wright · Orthopedic device
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Dec 1986
Decision
20d
Days
Class 2
Risk

K864626 is an FDA 510(k) clearance for the CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 20 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 Dow Corning Wright devices

Submission Details

510(k) Number K864626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1986
Decision Date December 15, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K864626.
VECSEI EXPANDING SCREW
K892925 · Howmedica Corp. · Aug 1989
OMNIFIT BONE SCREW
K873251 · Osteonics Corp. · Sep 1987
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · Howmedica Corp. · Dec 1986
BONE SCREW
K831873 · W.L. Gore & Associates, Inc. · Aug 1983
SEIDEL INTRAMEDULLARY PLUG
K792205 · Howmedica Corp. · Dec 1979
HERBERT BONE SCREW
K792022 · Zimmer, Inc. · Oct 1979