Cleared Traditional

K041961 - SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM

K041961 is an FDA 510(k) clearance for SCANDIUS ABSORBABLE ACL RECONSTRUCTION ..., manufactured by Scandius Biomedical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K041961 · Scandius Biomedical, Inc. · Orthopedic device
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Oct 2004
Decision
91d
Days
Class 2
Risk

K041961 is an FDA 510(k) clearance for the SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Scandius Biomedical, Inc. (Littleton, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 91 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 Scandius Biomedical, Inc. devices

FDA 510(k) Submission Details - K041961

510(k) Number K041961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2004
Decision Date October 20, 2004
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 805
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K041961.
ARTHREX TRIMIT FAMILY
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SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356 · Synthes (Usa) · Oct 2004
ENDOTINE MIDFACE B 4.5 DEVICE
K041835 · Coapt Systems, Inc. · Sep 2004
BIOPRO SUBTALAR IMPLANT
K041936 · Biopro, Inc. · Sep 2004