Cleared Traditional

K965228 - FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE

K965228 is an FDA 510(k) clearance for FASTERNER, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K965228 · United States Surgical, A Division of Tyco Healthc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
314d
Days
Class 2
Risk

K965228 is an FDA 510(k) clearance for the FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K965228

510(k) Number K965228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1996
Decision Date November 10, 1997
Days to Decision 314 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
192d slower than avg
Panel avg: 122d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K965228.
BIONX DISTAL RADIUS SCREW
K974876 · Bionx Implants, Inc. · Mar 1998
BIOROC EZ SUTURE BONE FASTENER
K973381 · Innovasive Devices, Inc. · Feb 1998
BIOABSORBABLE BANKART TACK
K973849 · Hogan & Hartson · Jan 1998
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
BIO-ANCHOR
K964805 · Linvatec Corp. · Jun 1997