# K081721: Tricos a Resorbable Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 6, 2008 after 49 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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: 5 generations back to K990131 (1999). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051722: Tricos T, Baxter Healthcare Corp (2005) Summary page 1.
- K073571: Tricos T Resorbable Bone Substitute, Baxter Healthcare Corporation (2008) Summary page 1.

## Indications for use
TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs A Resorbable Bone Substitute is intended to fill, augment, or reconstruct bony defects of the oral and maxillofacial region. Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the ingrowth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

Source page: https://510kreport.com/device/K081721
Methodology: https://510kreport.com/methodology