Cleared Traditional

CANNULATED INTERFERENCE SCREW SYSTEM (K901616) - FDA 510(k) Clearance

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

K901616 · Smith & Nephew Dyonics, Inc. · Orthopedic device
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Jun 1990
Decision
75d
Days
Class 2
Risk

K901616 is an FDA 510(k) clearance for the CANNULATED INTERFERENCE SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew Dyonics, Inc. (Andover, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Smith & Nephew Dyonics, Inc. devices

Submission Details

510(k) Number K901616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1990
Decision Date June 20, 1990
Days to Decision 75 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
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.

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 K901616.
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991
UNIVERSAL COMPRESSION SCREW
K904809 · Howmedica Corp. · Jun 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · Howmedica Corp. · Jun 1991
EXACTECH BONE SCREW
K896601 · Exactech, Inc. · Dec 1989
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · Depuy, Inc. · Nov 1989
ASNIS II GUIDED BONE SCREW
K895766 · Howmedica Corp. · Nov 1989