Cleared Traditional

GSO BONE FIXATION FASTENERS (K063589) - FDA 510(k) Clearance

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

K063589 · Gold Standard Orthopaedics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
61d
Days
Class 2
Risk

K063589 is an FDA 510(k) clearance for the GSO BONE FIXATION FASTENERS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Gold Standard Orthopaedics, LLC (Louisville, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Gold Standard Orthopaedics, LLC devices

Submission Details

510(k) Number K063589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2006
Decision Date January 31, 2007
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K063589.
ASNIS MICRO CANNULATED SCREW
K071092 · Howmedica Osteonics Corp. · May 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
K070906 · Zimmer, Inc. · May 2007
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
K070525 · Wrightmedicaltechnologyinc · Mar 2007
ARTHREX PUSHLOCK
K063479 · Arthrex, Inc. · Dec 2006
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
K061863 · Arthrex, Inc. · Oct 2006
FRS SCREW
K062352 · DePuy Orthopaedics, Inc. · Oct 2006