Cleared Special

K051341 - INION CPS BABY 1.5 BIOABSORBABLE FIXATI...

K051341 is an FDA 510(k) clearance for INION CPS BABY 1.5 BIOABSORBABLE FIXATI..., manufactured by Inion , Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 4-day FDA review.

K051341 · Inion , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
4d
Days
Class 2
Risk

K051341 is an FDA 510(k) clearance for the INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODE.... Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on May 27, 2005 after a review of 4 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.

View all Inion , Ltd. devices

FDA 510(k) Submission Details - K051341

510(k) Number K051341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2005
Decision Date May 27, 2005
Days to Decision 4 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
123d faster than avg
Panel avg: 127d · This submission: 4d
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 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K051341.
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K050204 · Synthes (Usa) · Mar 2005