Cleared Traditional

K993903 - WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013

K993903 is an FDA 510(k) clearance for WHITESIDE BIOMECHANICS TITANIUM LOW-PRO..., manufactured by Whiteside Biomechanics, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993903 · Whiteside Biomechanics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
90d
Days
Class 2
Risk

K993903 is an FDA 510(k) clearance for the WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Whiteside Biomechanics, Inc. (Creve Coeur, US). The FDA issued a Cleared decision on February 14, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Whiteside Biomechanics, Inc. devices

FDA 510(k) Submission Details - K993903

510(k) Number K993903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1999
Decision Date February 14, 2000
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

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 98
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K993903.
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa) · Jun 2001
SPL CRIMP SYSTEM
K002110 · Pioneer Surgical Technology · Oct 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · Pioneer Surgical Technology · Aug 2000
PIONEER SILICOAT STERNAL CABLE
K993286 · Pioneer Surgical Technology · Nov 1999
SYNTHES CERCLAGE POSITIONING PIN
K992891 · Synthes (Usa) · Nov 1999
SDB CERCLAGE SYSTEM
K992616 · Pioneer Surgical Technology · Oct 1999