Biosorbpdx Bioabsorbable Fixation System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K000836 ↗

FDA Product Code

JEY

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• Impact Suture Anchor. Model 433510

  Class II

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See all devices from Bionx Implants, Inc. →

• What is the BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM intended for?

  The BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM is a bioabsorbable fixation system intended for dental applications, as specified in the device description. It is designed as a Plate, Bone, to provide temporary stabilization in dental procedures where absorbable fixation is appropriate.

• How is the BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM supplied and by whom?

  The device is supplied by Bionx Implants, Inc., as stated in the manufacturer and supplier information. It is provided as a bone plate system for dental use, with no indication of reusability or specific packaging details beyond its role as a fixation implant.

• What regulatory pathway was used for the BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM?

  The device received FDA 510(k) clearance under submission number K000836, as explicitly noted in the authorizations section. This traditional 510(k) pathway was used to demonstrate substantial equivalence to a legally marketed predicate device.

• What is the classification and product code for the BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM?

  The device is classified as a Class 2 medical device with product code JEY, as indicated in the specifications. This classification aligns with regulation number 872.4760 and reflects its risk level and regulatory controls for bone plates in dental applications.

• Is the BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM reusable or single-use?

  The device is a bioabsorbable fixation system, which by design is intended to be absorbed by the body over time and is not meant for retrieval or reuse. Although the data does not explicitly state 'single-use', its bioabsorbable nature implies it is implanted and not intended for reprocessing or multiple uses.