# K231968: Tactoset® Injectable Bone Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: Dec 20, 2023 after 170 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K960978 (1996). 141 ancestors in all.
No later device cites it as a predicate yet.
0 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212083: Tactoset Injectable Bone Substitute, Anika Therapeutics, Inc. (2021) Summary page 5.
- K223915: Tactoset, Anika Therapeutics, Inc. (2023) Summary page 5.
- K201535: Cerament Bone Void Filler, Bonesupport AB (2020) Summary page 5.

## Indications for use
Tactoset® Injectable Bone Substitute is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically-created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Source page: https://510kreport.com/device/K231968
Methodology: https://510kreport.com/methodology