# K143546: Imbibe Aspirating XIA Taps

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Mar 19, 2015 after 94 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: 3 generations back to K023088 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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 4.

## Indications for use
The Imbibe Aspirating XIA TapsTM are 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 Aspirating XIA TapsTM are also for use as bone screw starters and bone taps.

Source page: https://510kreport.com/device/K143546
Methodology: https://510kreport.com/methodology