# K153306: Imbibe Needle

- Pathway: 510(k) (Special)
- Applicant: Orthovita, Inc.
- Decided: Dec 18, 2015 after 32 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K023088 (2002). 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)
- K140414: Imbibe Needle, Orthovita, Inc. (2014) Summary page 4.

## Indications for use
The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.

Source page: https://510kreport.com/device/K153306
Methodology: https://510kreport.com/methodology