Cleared Traditional

K953276 - ACUFEX TAG DELIVERY SYSTEM

K953276 is the FDA 510(k) clearance for ACUFEX TAG DELIVERY SYSTEM by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K953276 · Acufex Microsurgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
83d
Days
Class 2
Risk

K953276 is an FDA 510(k) clearance for the ACUFEX TAG DELIVERY SYSTEM. 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 October 5, 1995 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K953276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1995
Decision Date October 05, 1995
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 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 K953276.
SUTURE ANCHOR
K961578 · United States Surgical, A Division of Tyco Healthc · Jul 1996
SURGICAL DYNAMICS POP RIVET
K961585 · United States Surgical, A Division of Tyco Healthc · Jul 1996
PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
K950272 · Ethicon, Inc. · Jan 1996
HOWMEDICA MAINSTAY ANCHOR
K953531 · Howmedica Corp. · Sep 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · Ethicon, Inc. · May 1995
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346 · Acufex Microsurgical, Inc. · Apr 1995