Cleared Traditional

K992617 - HEX BUTTON

K992617 is an FDA 510(k) clearance for HEX BUTTON, manufactured by Pioneer Surgical Technology. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K992617 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
84d
Days
Class 2
Risk

K992617 is an FDA 510(k) clearance for the HEX BUTTON. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 84 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 Pioneer Surgical Technology devices

FDA 510(k) Submission Details - K992617

510(k) Number K992617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1999
Decision Date October 27, 1999
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 87
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K992617.
SYNTHES METALLIC SPIKED WASHERS
K013806 · Synthes (Usa) · Feb 2002
SPIKED WASHER
K011583 · Synthes (Usa) · Jan 2002
CANNULATED SCREW SYSTEM
K003496 · Pioneer Surgical Technology · Feb 2001
SOFT TISSUE SUTURE WASHER
K991135 · Depuy, Inc. · Apr 1999
DEPUY ORTHOTECH SPIKED WASHER
K983906 · DePuy Orthopaedics, Inc. · Dec 1998
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
K982354 · Special Devices, Inc. · Nov 1998