Cleared Traditional

K972599 - ACUFEX SCREW CANNULA

K972599 is the FDA 510(k) clearance for ACUFEX SCREW CANNULA by Smith & Nephew Endoscopy, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K972599 · Smith & Nephew Endoscopy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
67d
Days
Class 2
Risk

K972599 is an FDA 510(k) clearance for the ACUFEX SCREW CANNULA. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew Endoscopy, Inc. (Mansfield, US). The FDA issued a Cleared decision on September 19, 1997 after a review of 67 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 Endoscopy, Inc. devices

Submission Details

510(k) Number K972599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date September 19, 1997
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K972599.
ORTHOPEDIC SCREW SYSTEM
K972217 · Ferguson Medical · Nov 1997
THE CORIFIX LIGAMENT ANCHOR
K973005 · Corin USA · Nov 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · Depuy, Inc. · Oct 1997
STRYKER WEDGE INTERFERENCE SCREW SYSTEM
K972233 · Stryker Endoscopy · Aug 1997
OSTEO CANNULATED SCREW SYSTEM
K971800 · Osteonics Corp. · Jul 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · Osteonics Corp. · Jul 1997