# K190956: SCS 17-01

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: Jan 30, 2020 after 294 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: 12 generations back to K960978 (1996). 100 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173008: SCS 17-01, Anika Therapeutics, Inc. (2017) Summary page 5.

## Most influential descendants
- K212083: Tactoset Injectable Bone Substitute (2021), 2 descendants of its own
- K223915: Tactoset (2023), 1 descendant of its own
- K231968: Tactoset® Injectable Bone Substitute (2023), 0 descendants of its own

## Indications for use
SCS 17-01 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.

Source page: https://510kreport.com/device/K190956
Methodology: https://510kreport.com/methodology