# K170620: ReBOSSIS85

- Pathway: 510(k) (Traditional)
- Applicant: Orthorebirth Co., Ltd.
- Decided: Jun 23, 2017 after 114 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- 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: 5 generations back to K960978 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 4.

## Recalls of this device
- Mar 25, 2026 · Class II · Z-2132-2026: Resorbable bone void filler falls outside standard specifications.
- Mar 25, 2026 · Class II · Z-2131-2026: Resorbable bone void filler falls outside standard specifications.

## Indications for use
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydration or hydrated with blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

Source page: https://510kreport.com/device/K170620
Methodology: https://510kreport.com/methodology