# K140714: Porcine Anorganic Bone Mineral

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Jul 16, 2014 after 117 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871773 (1987). 9 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043034: Osteoguide Anorganic Bone Mineral Products, Collagen Matrix, Inc. (2005) Summary page 1.
- K952617: Bio-Oss, Geistlich-Pharma (1995) Summary page 1.

## Most influential descendants
- K173188: The Graft Natural Bone Substitute (2018), 1 descendant of its own
- K162158: Porcine Anorganic Bone Mineral in Delivery Applicator (2017), 1 descendant of its own
- K201859: Porcine Mineral Collagen Composite Moldable (2020), 0 descendants of its own
- K191737: The Graft Bone Substitute (2020), 0 descendants of its own

## Recalls of this device
- Oct 30, 2018 · Class III · Z-0752-2019: There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
- Nov 17, 2015 · Class III · Z-1173-2016: The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.

## Indications for use
Porcine Anorganic Bone Mineral 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/K140714
Methodology: https://510kreport.com/methodology