Cleared Traditional

K002020 - LACTOSORB MENISCAL SCREW

K002020 is the FDA 510(k) clearance for LACTOSORB MENISCAL SCREW by Biomet Manufacturing, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K002020 · Biomet Manufacturing, Inc. · Orthopedic device
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Aug 2000
Decision
53d
Days
Class 2
Risk

K002020 is an FDA 510(k) clearance for the LACTOSORB MENISCAL SCREW. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 25, 2000 after a review of 53 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 Biomet Manufacturing, Inc. devices

Submission Details

510(k) Number K002020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2000
Decision Date August 25, 2000
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 163
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K002020.
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
SYNTHES BIORESORBABLE SUTURE ANCHOR
K994161 · Synthes (Usa) · Jul 2000
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
K000506 · Arthrex, Inc. · May 2000
ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU
K990340 · Arthrex, Inc. · Jan 2000