# K140414: Imbibe Needle

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Apr 1, 2014 after 42 days
- Product code: LXH (Orthopedic Manual Surgical Instrument)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K023088 (2002). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050795: Imbibe Bone Marrow Aspiration Needle, Orthovita, Inc. (2005) Summary page 1.

## Most influential descendants
- K153306: Imbibe Needle (2015), 0 descendants of its own

## Recalls of this device
- Dec 4, 2014 · Class II · Z-0938-2015: There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.

## 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/K140414
Methodology: https://510kreport.com/methodology