# K211551: Wishbone HA

- Pathway: 510(k) (Traditional)
- Applicant: Wishbone SA
- Decided: Aug 20, 2021 after 93 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924408 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic, Geistlich Pharma AG (2013) Summary page 4.

## Indications for use
Wishbone HA is intended for the following uses: • Filling of infrabony periodontal defects; • Filling of periodontal defects in conjunction with products intended for guided tissue regeneration and guided bone regeneration; • Filling of defects after root resection, apicectomy and cystectomy; • Filling of extraction sockets to enhance preservation of the alveolar ridge; • Augmentation or reconstructive treatment of the alveolar ridge; • Elevation of the maxillary sinus floor; • Filling of peri-implant defects in conjunction with products intended for guided bone regeneration.

Source page: https://510kreport.com/device/K211551
Methodology: https://510kreport.com/methodology
