# K043034: Osteoguide Anorganic Bone Mineral Products

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Aug 4, 2005 after 274 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871773 (1987). 8 ancestors in all.
55 later devices descend from it; 9 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.
- K952617: Bio-Oss, Geistlich-Pharma (1995) Summary page 1.
- K970569: Bio-Blocks, Geistlich-Pharma (2000) Summary page 1.
- K974399: Bio-Oss Collagen, Geistlich-Pharma (1998) Summary page 1.

## Most influential descendants
- K052812: Ossimend (TM) Bone Graft Material (2006), 40 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- K181225: Altapore (2018), 6 descendants of its own
- K193075: Osteo3 ZP Putty (2020), 4 descendants of its own

## Recalls of this device
- Feb 2, 2022 · Class II · Z-0823-2022: NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
- Aug 25, 2015 · Class II · Z-1096-2016: On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.
- May 13, 2013 · Class II · Z-1097-2016: During the 36 month real time shelf life testing of NuOss XC Sinus (BMCU-Umbrella) to verify the 3 year shelf life designated for the device, 3 of 13 products did not pass the recovery test, which req

## Indications for use
Natural Mineral Bone Graft Substitutes are 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 periodontal defects * Filling of defects after root resection, apicocectomy, 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/K043034
Methodology: https://510kreport.com/methodology