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Caltrix Resorbable Bone Void Filler

by Ag Digital Technology Corp.

510(k) K083279

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083279 Date28 Jan 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CALTRIX RESORBABLE BONE VOID FILLER is a bone void filler composed of high-purity pharmaceutical-grade calcium sulfate pellets. It acts as an osteoconductive scaffold to facilitate new bone growth in non-structural bony voids or gaps in the extremities, spine, and pelvis. The device is biodegradable, biocompatible, and radiopaque.

The device is supplied as sterile calcium sulfate pellets for single use in surgical settings. It is intended to fill bone defects and is stored according to manufacturer specifications. Regulatory records indicate an FDA 510(k) submission with a substantially equivalent determination.

Other devices from Ag Digital Technology Corp.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical situations is the CALTRIX Resorbable Bone Void Filler intended for?

    It is designed to fill non‑structural bony voids or gaps in the extremities, spine, and pelvis, providing an osteoconductive scaffold that supports new bone growth while the material gradually resorbs.

  • How is the product supplied and what are the sterility requirements?

    The filler is supplied as sterile calcium sulfate pellets packaged for single‑use in the operating room. Sterility is maintained until the package is opened, ensuring a contamination‑free implant.

  • Can the CALTRIX filler be reused or stored for extended periods?

    It is a single‑use device and must be discarded after implantation. Storage must follow the manufacturer’s specifications, typically a controlled environment to preserve pellet integrity and sterility.

  • What material properties make CALTRIX suitable for bone void filling?

    The pellets are made from high‑purity pharmaceutical‑grade calcium sulfate, which is biodegradable, biocompatible, and radiopaque, allowing the surgeon to monitor placement while the scaffold safely resorbs as new bone forms.

  • What regulatory pathway was used for this device?

    The product received a traditional FDA 510(k) clearance with a substantially equivalent determination, indicating it was reviewed and found comparable to a legally marketed predicate device.