Cleared Traditional

K813581 - CRUCIATE LIGAMENT BUTTON

K813581 is the FDA 510(k) clearance for CRUCIATE LIGAMENT BUTTON by Biomet, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGS) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K813581 · Biomet, Inc. · General & Plastic Surgery device
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Mar 1982
Decision
85d
Days
Class 1
Risk

K813581 is an FDA 510(k) clearance for the CRUCIATE LIGAMENT BUTTON. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1982 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4930 - the FDA general and plastic surgery device 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, Inc. devices

Submission Details

510(k) Number K813581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1981
Decision Date March 23, 1982
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGS Retention Device, Suture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4930
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGS Retention Device, Suture

All 11
Devices cleared under the same product code (KGS) and FDA review panel - the closest regulatory comparables to K813581.
ACUFEX FIXATION BUTTON
K884565 · Acufex Microsurgical, Inc. · Feb 1989
HEWSON A.C.L. GUIDE SET
K872608 · Concept, Inc. · Sep 1987
BIOMER * PLEDGET SUTURE BUTTRESS
K832138 · Ethicon, Inc. · May 1984
ETHICON* SURGICAL SUTURES W/COMPRESS BOL
K812819 · Ethicon, Inc. · Nov 1981
HEWSON LIGAMENT BUTTON
K792004 · Richard'S Medical Equip., Inc. · Nov 1979
SUTURE RETENTION CLAMP
K771554 · Concept, Inc. · Sep 1977