# K240450: Citrepore™

- Pathway: 510(k) (Traditional)
- Applicant: Acuitive Technologies, Inc.
- Decided: Nov 6, 2024 after 265 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: 7 generations back to K960978 (1996). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 5.

## Indications for use
CITREPORE™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. CITREPORE is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. CITREPORE is intended to be used for filling bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, CITREPORE resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K240450
Methodology: https://510kreport.com/methodology