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THERIFIL Bone Filler

by Therics, LLC

510(k) K031040

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 NumberK031040 Date24 Jul 2003ClearedStatusActive

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  • Withdrawn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
FDA applicant
Therics, Inc.
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.

THERIFIL Bone Filler is a synthetic bone void filler composed of beta-tricalcium phosphate. It is designed to fill gaps or voids in osseous defects of the extremities, spine, and pelvis that are not intrinsic to bone stability. The device creates an interlocking network within the defect site that resorbs during healing and is replaced by bone.

THERIFIL Bone Filler is supplied as a sterile device and is intended for single use. It is manufactured by Therics, LLC and has FDA 510(k) clearance with product code MQV. The device is stored according to manufacturer instructions and is MRI safe.

Other devices from Therics, LLC

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 is THERIFIL Bone Filler used for?

    THERIFIL Bone Filler is designed to fill gaps or voids in osseous defects of the extremities, spine, and pelvis that are not intrinsic to bone stability. It creates an interlocking network within the defect site that resorbs during healing and is replaced by bone.

  • How is THERIFIL Bone Filler supplied and is it reusable?

    THERIFIL Bone Filler is supplied as a sterile device and is intended for single use only. It should not be reused or resterilized as this may compromise its safety and effectiveness.

  • What are the storage requirements for THERIFIL Bone Filler?

    THERIFIL Bone Filler should be stored according to the manufacturer's instructions. While specific storage conditions aren't detailed in the provided information, it's important to follow the manufacturer's guidelines to maintain product integrity.

  • Is THERIFIL Bone Filler MRI safe?

    Yes, THERIFIL Bone Filler is MRI safe, meaning it can be safely used in patients undergoing MRI procedures without causing significant image artifacts or safety concerns.