Cleared Special

PIONEER SILICOAT STERNAL CABLE (K993286) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K993286 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
53d
Days
Class 2
Risk

K993286 is an FDA 510(k) clearance for the PIONEER SILICOAT STERNAL CABLE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on November 23, 1999 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pioneer Surgical Technology devices

Submission Details

510(k) Number K993286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1999
Decision Date November 23, 1999
Days to Decision 53 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 50
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K993286.
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · Synthes (Usa) · May 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · Smith & Nephew, Inc. · May 2003
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa) · Jun 2001
SYNTHES CERCLAGE POSITIONING PIN
K992891 · Synthes (Usa) · Nov 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · Howmedica Osteonics Corp. · Feb 1999
BMP CABLE SYSTEM
K982545 · Biomet, Inc. · Oct 1998