Cleared Traditional

K961555 - ACUFEX TAG BIOABSORBABLE ANCHORS

K961555 is an FDA 510(k) clearance for ACUFEX TAG BIOABSORBABLE ANCHORS, manufactured by Acufex Microsurgical, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K961555 · Acufex Microsurgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
79d
Days
Class 2
Risk

K961555 is an FDA 510(k) clearance for the ACUFEX TAG 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 July 10, 1996 after a review of 79 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

FDA 510(k) Submission Details - K961555

510(k) Number K961555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date July 10, 1996
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

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 190
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K961555.
HOWMEDICA MAINSTAY ANCHOR
K965175 · Howmedica Corp. · Mar 1997
MLI MODULAR STAPLE
K962705 · Medicinelodge, Inc. · Oct 1996
MITEK MICRO ANCHOR
K962793 · Mitek Products · Oct 1996
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
LACTOSORB SUTURE ANCHOR
K954443 · Poly-Medics,Inc. · Jan 1996