Cleared Traditional

K934044 - ANTERIOR CRUCIATE LIGAMENT (ACL) SURGIC...

K934044 is an FDA 510(k) clearance for ANTERIOR CRUCIATE LIGAMENT (ACL) SURGIC..., 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 203-day FDA review.

K934044 · Smith and Nephew Donjoy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
203d
Days
Class 2
Risk

K934044 is an FDA 510(k) clearance for the ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM. 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 March 10, 1994 after a review of 203 days - an extended review 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: 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 - K934044

510(k) Number K934044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1993
Decision Date March 10, 1994
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K934044.
CORTICAL BONE SCREW
K931790 · Onyx Medical Corp. · Apr 1994
CANCELLOUS BONE SCREW
K934615 · Onyx Medical Corp. · Apr 1994
CANCELLOUS BONE SCREW
K934616 · Onyx Medical Corp. · Apr 1994
FULLY THREADED ALTA CANCELLOUS BONE SCREW
K931524 · Howmedica Corp. · Mar 1994
OREGON FIXATION SYSTEM INTERFERENCE SCREW
K932027 · Acu Med, Inc. · Feb 1994
CONCEPT CANNULATED INTEREFERENCE SCREW
K933352 · Linvatec Corp. · Feb 1994