Cleared Traditional

THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* (K973281) - FDA 510(k) Clearance

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

K973281 · 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
62d
Days
Class 2
Risk

K973281 is an FDA 510(k) clearance for the THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*. 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 3, 1997 after a review of 62 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K973281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date November 03, 1997
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
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 122
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K973281.
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
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
K971358 · Arthrex, Inc. · Jul 1997
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
K970896 · Ethicon, Inc. · Jun 1997
DEPUY DUPONT PHANTOM SUTURE ANCHOR
K964521 · Depuy, Inc. · Feb 1997