510(k) · Cleared
ClearedStryker Kwic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthovita, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 5, 2014 as substantially equivalent to K050795 (Orthovita, Inc., 2005) and 1 other predicate after a 63-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Jun 5, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K023088 (2002). 7 ancestors in all, the oldest K940025 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK023088 Bone Graft Syringe, Model 8600-00X0Wrightmedicaltechnologyinc · 2002
- 2 generations backK041991 Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc. · 2004
- 1 generation backK050795 Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005
- This deviceK140868 Stryker Kwic NeedleOrthovita, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK201743 ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V. · 2021
Most influential descendants
Showing 1 of 1 · See all- K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023088 | Bone Graft Syringe, Model 8600-00X0 | Wrightmedicaltechnologyinc | 2002 | — |
| −2 | K041991 | Aspirex - Bone Marrow Aspirate Kit | Isotis Orthobiologics, Inc. | 2004 | — |
| −1 | K050795 | Imbibe Bone Marrow Aspiration Needle | Orthovita, Inc. | 2005 | — |
| 0 (this device) | K140868 | Stryker Kwic Needle | Orthovita, Inc. | 2014 | — |
| +1 | K201743 | ClarifEye R1.0, ClarifEye Needle | Philips Medical Systems Nederlands B.V. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050795 | Imbibe Bone Marrow Aspiration NeedleSummary page 1…Class 11 Product Code: HAW KNW 3. Predicate Device(s) Orthovita Inc.'s Imbibe Needle (K050795) Stryker Leibinger's Navigation System Spine & Fluoroscopy Module (K012380) 4. Device Description The Stryker KWIC (K-… | 2005 |
| * | K012380 | Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual FluoroscopySummary page 1…KNW 3. Predicate Device(s) Orthovita Inc.'s Imbibe Needle (K050795) Stryker Leibinger's Navigation System Spine & Fluoroscopy Module (K012380) 4. Device Description The Stryker KWIC (K-wire Insertion Cannulated) Needle is a manually operated needle that is u… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201743 | ClarifEye R1.0, ClarifEye Needle | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K201743 (Philips Medical Systems Nederlands B.V., 2021) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K050795.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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…
Read the full statement (122 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140868: Stryker Kwic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140868
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026