Cleared Traditional

K010351 - INION CPS BABY 1.5 BIOABSORBABLE FIXATI...

K010351 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 Traditional 510(k) pathway after a 37-day FDA review.

K010351 · Inion , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
37d
Days
Class 2
Risk

K010351 is an FDA 510(k) clearance for the INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on March 15, 2001 after a review of 37 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 Inion , Ltd. devices

FDA 510(k) Submission Details - K010351

510(k) Number K010351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2001
Decision Date March 15, 2001
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
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 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K010351.
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380 · Bioplate, Inc. · May 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · Synthes (Usa) · May 2001
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
K010352 · Inion , Ltd. · Mar 2001
SMF RESORBABLE MESHES AND SHEETS
K003786 · Synthes (Usa) · Feb 2001
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
K003549 · Codman & Shurtleff, Inc. · Feb 2001