Cleared Special

K042517 - BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS

K042517 is an FDA 510(k) clearance for BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 ..., manufactured by Linvatec Biomaterials, Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 23-day FDA review.

K042517 · Linvatec Biomaterials, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
23d
Days
Class 2
Risk

K042517 is an FDA 510(k) clearance for the BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Linvatec Biomaterials, Ltd. (Tampere, FI). The FDA issued a Cleared decision on October 8, 2004 after a review of 23 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. 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.

FDA 510(k) Submission Details - K042517

510(k) Number K042517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2004
Decision Date October 08, 2004
Days to Decision 23 days
Submission Type Special
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
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 293
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K042517.
MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
K043297 · Medicon EG · Feb 2005
MODIFICATION TO SYNTHES CRANIAL PLATES
K042987 · Synthes (Usa) · Nov 2004
SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
K042365 · Synthes (Usa) · Nov 2004
BONAMATES SERIES
K040650 · Biotech One, Inc. · Jun 2004
LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
K030425 · Walter Lorenz Surgical, Inc. · May 2004
THE GNATHOMETER
K033092 · Ortho Gnathics, LLC · Apr 2004
K042517 · BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
Download PDF FDA Summary Linvatec Biomaterials…