Cleared Traditional

K973323 - ACL CLIP-IN

K973323 is the FDA 510(k) clearance for ACL CLIP-IN by Innovasive Devices, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973323 · Innovasive Devices, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
88d
Days
Class 2
Risk

K973323 is an FDA 510(k) clearance for the ACL CLIP-IN. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Innovasive Devices, Inc. (Marlboro, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 88 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 Innovasive Devices, Inc. devices

Submission Details

510(k) Number K973323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1997
Decision Date December 01, 1997
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 412
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K973323.
ACUMED SUTURE ANCHOR
K980103 · Acu Med, Inc. · Mar 1998
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER
K974049 · Innovasive Devices, Inc. · Feb 1998
CRANIOFACIAL ANCHORS
K974136 · Biomet, Inc. · Jan 1998
CSCO FOREHEAD FIXATION SYSTEM
K963502 · Howmedica Corp. · Oct 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · Innovasive Devices, Inc. · Sep 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356 · Innovasive Devices, Inc. · Aug 1997