Cleared Traditional

K984490 - SUTURELESS ANCHOR

K984490 is the FDA 510(k) clearance for SUTURELESS ANCHOR by Innovasive Devices, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K984490 · Innovasive Devices, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
74d
Days
Class 2
Risk

K984490 is an FDA 510(k) clearance for the SUTURELESS ANCHOR. 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 March 1, 1999 after a review of 74 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 K984490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1998
Decision Date March 01, 1999
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
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 159
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K984490.
ENDOPEARL
K984171 · Linvatec Corp. · Apr 1999
HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
K990361 · Arthrex, Inc. · Apr 1999
BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B
K983843 · Arthrex, Inc. · Mar 1999
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