Cleared Traditional

K946346 - ACUFEX TAG BIOABSORBABLE ANCHORS

K946346 is the FDA 510(k) clearance for ACUFEX TAG BIOABSORBABLE ANCHORS by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K946346 · Acufex Microsurgical, Inc. · Orthopedic device
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Apr 1995
Decision
117d
Days
Class 2
Risk

K946346 is an FDA 510(k) clearance for the ACUFEX TAG(R) BIOABSORBABLE ANCHORS. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on April 26, 1995 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K946346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date April 26, 1995
Days to Decision 117 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
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 - JDR Staple, Fixation, Bone

All 97
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K946346.
ACUFEX TAG DELIVERY SYSTEM
K953276 · Acufex Microsurgical, Inc. · Oct 1995
HOWMEDICA MAINSTAY ANCHOR
K953531 · Howmedica Corp. · Sep 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · Ethicon, Inc. · May 1995
BIOABSORBABLE INTERFERENCE SCREW
K943548 · Acufex Microsurgical, Inc. · Mar 1995
ACUFEX TAG ANCHOR
K934867 · Acufex Microsurgical, Inc. · Feb 1995
ARTHREX STAPLES
K943492 · Arthrex, Inc. · Feb 1995