Cleared Traditional

K990804 - STAYFUSE

K990804 is the FDA 510(k) clearance for STAYFUSE by Pioneer Surgical Technology. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K990804 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
50d
Days
Class 2
Risk

K990804 is an FDA 510(k) clearance for the STAYFUSE. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on April 29, 1999 after a review of 50 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 Pioneer Surgical Technology devices

Submission Details

510(k) Number K990804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date April 29, 1999
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
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 586
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K990804.
BIO-INTERFERENCE SCREW
K990454 · Innovasive Devices, Inc. · Jul 1999
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · Aap Implantate AG · Apr 1999
ULTIMAX CORTICAL BONE SCREWS
K990513 · Biodynamic Technologies, Inc. · Mar 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209 · Biomet, Inc. · Feb 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592 · Sulzer Orthopedics, Inc. · Jan 1999