Cleared Traditional

FIXATION SYSTEM (K983318) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983318 · General Surgical Innovations · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
161d
Days
Class 2
Risk

K983318 is an FDA 510(k) clearance for the FIXATION SYSTEM. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by General Surgical Innovations (Cupertino, US). The FDA issued a Cleared decision on March 1, 1999 after a review of 161 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all General Surgical Innovations devices

Submission Details

510(k) Number K983318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1998
Decision Date March 01, 1999
Days to Decision 161 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 115d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 107
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K983318.
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · United States Surgical, A Division of Tyco Healthc · Nov 2002
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc · Dec 2001
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
AUTO SUTURE SITE MARKER CLIP
K983400 · United States Surgical, A Division of Tyco Healthc · Feb 1999
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · United States Surgical, A Division of Tyco Healthc · Oct 1995
SURGICAL STAPLE
K942606 · United States Surgical, A Division of Tyco Healthc · Aug 1994