Cleared Traditional

K010690 - SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR

K010690 is the FDA 510(k) clearance for SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR by Synthes (Usa). It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K010690 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
71d
Days
Class 2
Risk

K010690 is an FDA 510(k) clearance for the SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 18, 2001 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - the FDA dental 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 Synthes (Usa) devices

Submission Details

510(k) Number K010690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2001
Decision Date May 18, 2001
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 Dental devices follow this clearance model.

Regulatory Peers - DZL Screw, Fixation, Intraosseous

All 41
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K010690.
SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
K021850 · Synthes (Usa) · Jun 2002
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW
K021522 · Walter Lorenz Surgical, Inc. · May 2002
THE AUTOTAC SYSTEM
K011675 · BioHorizons Implant Systems, Inc. · Jun 2001
SYNTHES (USA) IMF SCREWS
K010527 · Synthes (Usa) · Apr 2001
SYNTHES 1.5MM TI BROW LIFT SCREW
K002935 · Synthes (Usa) · Nov 2000
LACTOSORB PUSH SCREW
K002423 · Biomet, Inc. · Oct 2000