Cleared Traditional

K981340 - INNOVASIVE DEVICES MENISCAL DART REPAIR...

K981340 is the FDA 510(k) clearance for INNOVASIVE DEVICES MENISCAL DART REPAIR... by Innovasive Devices, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K981340 · Innovasive Devices, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
70d
Days
Class 2
Risk

K981340 is an FDA 510(k) clearance for the INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Innovasive Devices, Inc. (Marlboro, US). The FDA issued a Cleared decision on June 22, 1998 after a review of 70 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 Innovasive Devices, Inc. devices

Submission Details

510(k) Number K981340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1998
Decision Date June 22, 1998
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 162
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K981340.
LACTOSORB MENISCAL REPAIR DEVICE
K982095 · Biomet, Inc. · Jan 1999
BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
K983186 · Linvatec Corp. · Oct 1998
PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW
K982900 · Depuy, Inc. · Aug 1998
BIOROC EZ SUTURE BONE FASTENER
K973381 · Innovasive Devices, Inc. · Feb 1998
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · United States Surgical, A Division of Tyco Healthc · Nov 1997
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
K973281 · United States Surgical, A Division of Tyco Healthc · Nov 1997