Cleared Traditional

HEX BUTTON (K992617) - FDA 510(k) Clearance

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

K992617 · Pioneer Surgical Technology · Orthopedic device
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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

Submission Details

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
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.

Device Classification

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 51
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K992617.
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · Arthrex, Inc. · Dec 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · Synthes (Usa) · Feb 2002
SPIKED WASHER
K011583 · Synthes (Usa) · Jan 2002
SOFT TISSUE SUTURE WASHER
K991135 · Depuy, Inc. · Apr 1999
DEPUY ORTHOTECH SPIKED WASHER
K983906 · DePuy Orthopaedics, Inc. · Dec 1998
SYNTHES SCHUHLI IMPLANT SYSTEM
K980944 · Synthes (Usa) · Apr 1998