Cleared Traditional

K973874 - ACL CLIP-IN PLATE

K973874 is an FDA 510(k) clearance for ACL CLIP-IN PLATE, 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 196-day FDA review.

K973874 · Innovasive Devices, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
196d
Days
Class 2
Risk

K973874 is an FDA 510(k) clearance for the ACL CLIP-IN PLATE. 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 April 24, 1998 after a review of 196 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 Innovasive Devices, Inc. devices

FDA 510(k) Submission Details - K973874

510(k) Number K973874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1997
Decision Date April 24, 1998
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
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 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K973874.
DEPUY ORTHOTECH CATERA SUTURE ANCHOR
K980595 · DePuy Orthopaedics, Inc. · May 1998
INNOVASIVE LINX TIBIAL LIGAMENT FASTENER
K980491 · Innovasive Devices, Inc. · Apr 1998
INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
K980334 · Innovasive Devices, Inc. · Apr 1998
HARPOON SUTURE ANCHORS
K973775 · Biomet, Inc. · Apr 1998
ACUMED SUTURE ANCHOR
K980103 · Acu Med, Inc. · Mar 1998
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER
K974049 · Innovasive Devices, Inc. · Feb 1998