Cleared Traditional

K961649 - ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER

K961649 is an FDA 510(k) clearance for ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER, manufactured by Smith & Nephew Endoscopy, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961649 · Smith & Nephew Endoscopy, Inc. · Orthopedic device
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Jul 1996
Decision
77d
Days
Class 2
Risk

K961649 is an FDA 510(k) clearance for the ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER. 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 July 16, 1996 after a review of 77 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

FDA 510(k) Submission Details - K961649

510(k) Number K961649 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 30, 1996
Decision Date July 16, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K961649.
MEDICINELODGE, INC. SET SCREW
K961905 · Medicinelodge, Inc. · Aug 1996
SYNTHES 7.0/7.3 MM CANNULATED SCREWS
K962011 · Synthes (Usa) · Aug 1996
SUBTALAR MBA SYSTEM
K960692 · Kinetikos Medical, Inc. · Jul 1996
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234 · Depuy, Inc. · Jun 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704 · Depuy, Inc. · Jun 1996
WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW
K961157 · Whiteside Biomechanics, Inc. · May 1996