Cleared Traditional

K993073 - SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030

K993073 is an FDA 510(k) clearance for SMART SCREW ACL MODELS 237020, manufactured by Bionx Implants, Ltd.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K993073 · Bionx Implants, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
83d
Days
Class 2
Risk

K993073 is an FDA 510(k) clearance for the SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020.... Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Bionx Implants, Ltd. (Tampere, FI). The FDA issued a Cleared decision on December 6, 1999 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Bionx Implants, Ltd. devices

FDA 510(k) Submission Details - K993073

510(k) Number K993073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1999
Decision Date December 06, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 198
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