# K201859: Porcine Mineral Collagen Composite Moldable

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Sep 11, 2020 after 67 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.
No later device cites it as a predicate yet.
0 of 11 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.

## Indications for use
Porcine Mineral Collagen Composite Moldable is indicated for: • 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/K201859
Methodology: https://510kreport.com/methodology