# K140868: Stryker Kwic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Jun 5, 2014 after 63 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy, Stryker Leibinger (2001) Summary page 1.

## Most influential descendants
- K201743: ClarifEye R1.0, ClarifEye Needle (2021), 0 descendants of its own

## Indications for use
The Stryker KWIC Needle is a manual surgical instrument intended to be used in spine surgery to facilitate placement of guidewires. The device may also be used to aspirate autologous blood or bone marrow by use of a syringe. The blood or bone marrow may be combined with bone graft or bone void filler. The Stryker KWIC Needle may be used as part of a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The KWIC Needle is indicated for use in spinal surgical procedures in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull or vertebra, can be identified relative to medical images.

Source page: https://510kreport.com/device/K140868
Methodology: https://510kreport.com/methodology