Cleared Traditional

K010499 - SYNTHES (USA) MIDFACE DISTRACTOR

K010499 is an FDA 510(k) clearance for SYNTHES (USA) MIDFACE DISTRACTOR, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K010499 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
71d
Days
Class 2
Risk

K010499 is an FDA 510(k) clearance for the SYNTHES (USA) MIDFACE DISTRACTOR. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 3, 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 872.4760 - 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

FDA 510(k) Submission Details - K010499

510(k) Number K010499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2001
Decision Date May 03, 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.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K010499.
LACTOSORB RAPIDFLAP
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K010351 · Inion , Ltd. · Mar 2001
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352 · Inion , Ltd. · Mar 2001
BIOSORBFX AND BIOSORBPDX MESH
K010687 · Bionx Implants, Inc. · Mar 2001