Cleared Traditional

K000836 - BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

K000836 is an FDA 510(k) clearance for BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM, manufactured by Bionx Implants, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K000836 · Bionx Implants, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
86d
Days
Class 2
Risk

K000836 is an FDA 510(k) clearance for the BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Tampere, FI). The FDA issued a Cleared decision on June 8, 2000 after a review of 86 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 Bionx Implants, Inc. devices

FDA 510(k) Submission Details - K000836

510(k) Number K000836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date June 08, 2000
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 207
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K000836.
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THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
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LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
K001238 · Walter Lorenz Surgical, Inc. · May 2000
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
K994154 · KLS-Martin L.P. · Feb 2000
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K992682 · Medartis AG · Nov 1999