Cleared Traditional

K000694 - PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)

K000694 is an FDA 510(k) clearance for PECTOFIX DYNAMIC STERNAL FIXATION SYSTE..., manufactured by Pectofix, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K000694 · Pectofix, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
71d
Days
Class 2
Risk

K000694 is an FDA 510(k) clearance for the PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF). Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Pectofix, Inc. (Metuchen, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 71 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. 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 Pectofix, Inc. devices

FDA 510(k) Submission Details - K000694

510(k) Number K000694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2000
Decision Date May 11, 2000
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 109
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K000694.
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
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903 · Whiteside Biomechanics, Inc. · Feb 2000
PIONEER SILICOAT STERNAL CABLE
K993286 · Pioneer Surgical Technology · Nov 1999
SYNTHES CERCLAGE POSITIONING PIN
K992891 · Synthes (Usa) · Nov 1999