Cleared Traditional

K003984 - SUPER REVO SUTURE ANCHOR

K003984 is the FDA 510(k) clearance for SUPER REVO SUTURE ANCHOR by Linvatec Corp.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K003984 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
83d
Days
Class 2
Risk

K003984 is an FDA 510(k) clearance for the SUPER REVO SUTURE ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on March 19, 2001 after a review of 83 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 Linvatec Corp. devices

Submission Details

510(k) Number K003984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date March 19, 2001
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 158
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K003984.
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · Smith & Nephew, Inc. · Nov 2001
ARTHREX BIO-POST AND WASHER
K011495 · Arthrex, Inc. · Aug 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · Smith & Nephew, Inc. · Jun 2001
SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM
K003743 · Synthes (Usa) · Feb 2001
LACTOSORB SCREW ANCHOR
K003273 · Biomet, Inc. · Jan 2001
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
K003227 · Arthrex, Inc. · Jan 2001