Cleared Traditional

K973323 - ACL CLIP-IN

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

K973323 · Innovasive Devices, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K973323

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.

MBI Device Classification - Class 2, Special Controls

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 565
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K973323.
PEBA ANCHOR/SUTURE COMBINATION
K972326 · Orthopaedic Biosystems, Ltd. · Feb 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119 · Mitek Products · Jan 1998
CRANIOFACIAL ANCHORS
K974136 · Biomet, Inc. · Jan 1998
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · Mitek Products · Nov 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502 · Howmedica Corp. · Oct 1997
STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972622 · Influence, Inc. · Oct 1997