# K162158: Porcine Anorganic Bone Mineral in Delivery Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Feb 9, 2017 after 191 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: 4 generations back to K871773 (1987). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140714: Porcine Anorganic Bone Mineral, Collagen Matrix, Inc. (2014) Summary page 4.

## Most influential descendants
- K191737: The Graft Bone Substitute (2020), 0 descendants of its own

## Indications for use
Porcine Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as: Augmentation or reconstructive treatment of alveolar ridge Filling of infrabony periodontal defects Filling of defects after root resection, apicoectomy, and cystectomy Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.

Source page: https://510kreport.com/device/K162158
Methodology: https://510kreport.com/methodology