Cleared Traditional

BIOABSORBABLE BANKART TACK (K973849) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973849 · Hogan & Hartson · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
90d
Days
Class 2
Risk

K973849 is an FDA 510(k) clearance for the BIOABSORBABLE BANKART TACK. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on January 6, 1998 after a review of 90 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 Hogan & Hartson devices

Submission Details

510(k) Number K973849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1997
Decision Date January 06, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 123
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K973849.
BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B
K983843 · Arthrex, Inc. · Mar 1999
LACTOSORB MENISCAL REPAIR DEVICE
K982095 · Biomet, Inc. · Jan 1999
PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW
K982900 · Depuy, Inc. · Aug 1998
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · United States Surgical, A Division of Tyco Healthc · Nov 1997
THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
K973281 · United States Surgical, A Division of Tyco Healthc · Nov 1997
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
K971358 · Arthrex, Inc. · Jul 1997