Cleared Traditional

K945236 - AIMS CANNULATED ACL SCREW (7MM DIAMETER)

K945236 is an FDA 510(k) clearance for AIMS CANNULATED ACL SCREW (7MM DIAMETER), manufactured by Smith and Nephew Donjoy, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K945236 · Smith and Nephew Donjoy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
99d
Days
Class 2
Risk

K945236 is an FDA 510(k) clearance for the AIMS CANNULATED ACL SCREW (7MM DIAMETER). Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith and Nephew Donjoy, Inc. (Carsbad, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith and Nephew Donjoy, Inc. devices

FDA 510(k) Submission Details - K945236

510(k) Number K945236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1994
Decision Date February 03, 1995
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 691
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K945236.
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · Linvatec Corp. · May 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · Acu Med, Inc. · May 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426 · Arthrex, Inc. · Apr 1995
BONE MULCH SCREW
K941941 · Biomet, Inc. · Feb 1995
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213 · Howmedica Corp. · Dec 1994
CORTICAL BONE SCREW
K942340 · Acu Med, Inc. · Dec 1994