# K240453: ReBOSSIS

- Pathway: 510(k) (Traditional)
- Applicant: Orthorebirth Co., Ltd.
- Decided: Mar 4, 2024 after 18 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: 26 generations back to K841189 (1984). 341 ancestors in all.
No later device cites it as a predicate yet.
1 of 342 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232315: Catalyst Bone Void Filler, Ossdsign AB (2023) Summary page 5.
- K172573: ReBOSSIS85, Orthorebirth Co., Ltd. (2017) Summary page 5.

## 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
ReBOSSIS 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. ReBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, posterolateral spine, and intervertebral disc space). In the extremities and pelvis ReBOSSIS may be used without hydration or hydrated with blood. In the posterolateral spine and intervertebral disc space, ReBOSSIS is to be used hydrated with bone marrow aspirate and mixed with autograft bone. When used in intervertebral body fusion procedures, ReBOSSIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. 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/K240453
Methodology: https://510kreport.com/methodology