Cleared Traditional

K896310 - ACUFEX FIXATION BUTTON

Also marketed or referenced as:
RETENTION BAR, WEDGE

K896310 is the FDA 510(k) clearance for ACUFEX FIXATION BUTTON by Acufex Microsurgical, Inc.. It is a Class 1 General & Plastic Surgery device (product code KGS) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K896310 · Acufex Microsurgical, Inc. · General & Plastic Surgery device
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Nov 1989
Decision
19d
Days
Class 1
Risk

K896310 is an FDA 510(k) clearance for the ACUFEX FIXATION BUTTON. Classified as Retention Device, Suture (product code KGS), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Norwood, US). The FDA issued a Cleared decision on November 20, 1989 after a review of 19 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K896310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1989
Decision Date November 20, 1989
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
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 K896310.
ACUFEX ROTATOR CUFF FIXATION BUTTON
K941740 · Acufex Microsurgical, Inc. · Jun 1995
VENTROFIL TENSION RELIEF SUTURE SET
K904435 · Aesculap, Inc. · Aug 1991
SURGICAL RETENTION BAR
K902001 · Acufex Microsurgical, Inc. · May 1990
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