# K062691: Comporus

- Pathway: 510(k) (Traditional)
- Applicant: Takiron Co., Ltd.
- Decided: Apr 15, 2008 after 582 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960978 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, Interpore Intl. (1998) Summary page 1.
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita, Inc. (2003) Summary page 1.
- K030288: Polygraft Bone Graft Substitute, Osteobiologics, Inc. (2003) Summary page 1.
- K023703: BI-Ostetic, Berkeley Advanced Biomaterials, Inc. (2003) Summary page 1.

## Indications for use
Comporus TM is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus TM is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.

Source page: https://510kreport.com/device/K062691
Methodology: https://510kreport.com/methodology