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Altapore Shape

by Baxter Healthcare Corporation 510(k)

Active United States

510(k) K191513

Overview

The Altapore Shape is a resorbable calcium salt bone void filler device, classified under 21 CFR 888.3045. It consists of Silicate Substituted Calcium Phosphate Enhanced Porosity (SiCaP EP) granules designed to mimic human cancellous bone structure, combined with a poloxamer carrier for improved handling.

This device is supplied as a single-use, sterile strip and is intended for filling bone voids or defects. It is regulated under FDA 510(k) clearance (K191513) and falls under Class II orthopedic devices. No MRI safety or reusable specifications are noted in the data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK191513 Date19 Oct 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Altapore Shape used for in clinical practice?

    The Altapore Shape is designed to fill bone voids or defects, such as those created during orthopedic surgeries. Its composition of Silicate Substituted Calcium Phosphate Enhanced Porosity (SiCaP EP) granules mimics human cancellous bone, providing structural support while gradually resorbing over time.

  • Is the Altapore Shape intended for reuse, or is it single-use only?

    The Altapore Shape is explicitly supplied as a single-use device. This ensures sterility and safety for each patient, as it is packaged as a sterile strip and not intended for reprocessing or reuse.

  • How is the Altapore Shape supplied, and what does the sterile packaging ensure?

    The Altapore Shape comes as a sterile strip, meaning it is pre-packaged in a sterile barrier system to maintain cleanliness before use. This ensures the device is free from contamination, ready for immediate clinical application in filling bone voids or defects.

  • What regulatory pathway was followed for the FDA clearance of the Altapore Shape?

    The Altapore Shape received FDA clearance through a 510(k) submission (K191513) under the Traditional review pathway, classified as a Class II orthopedic device. The submission was reviewed by the Orthopedic (OR) Advisory Committee and determined to be Substantially Equivalent to a predicate device.