# K231672: S1

- Pathway: 510(k) (Traditional)
- Applicant: Medpark Co., Ltd.
- Decided: Oct 13, 2023 after 127 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 5.

## Indications for use
S1 is intended for the following uses: • Augmentation or reconstructive treatment of the alveolar ridge; • Filling of infrabony periodontal defects • Filling of defects after root resection, apicocectomy, and cystectomy • Filling of extraction sockets to enhance preservation of the alveolar ridge • Elevation of the maxillary sinus floor • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Source page: https://510kreport.com/device/K231672
Methodology: https://510kreport.com/methodology