Cleared Traditional

K973381 - BIOROC EZ SUTURE BONE FASTENER

K973381 is an FDA 510(k) clearance for BIOROC EZ SUTURE BONE FASTENER, manufactured by Innovasive Devices, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K973381 · Innovasive Devices, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
163d
Days
Class 2
Risk

K973381 is an FDA 510(k) clearance for the BIOROC EZ SUTURE BONE FASTENER. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Innovasive Devices, Inc. (Marlboro, US). The FDA issued a Cleared decision on February 18, 1998 after a review of 163 days - an extended review 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: 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 Innovasive Devices, Inc. devices

FDA 510(k) Submission Details - K973381

510(k) Number K973381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date February 18, 1998
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
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 184
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K973381.
INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM
K981340 · Innovasive Devices, Inc. · Jun 1998
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR
K972783 · Bionx Implants, Inc. · Apr 1998
BIONX DISTAL RADIUS SCREW
K974876 · Bionx Implants, Inc. · Mar 1998
BIOABSORBABLE BANKART TACK
K973849 · Hogan & Hartson · Jan 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