510(k) · Cleared
ClearedKestrel Posterior Cervical Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omni Surgical, LLC Dba Spine360 · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 22, 2014 as substantially equivalent to K061943 (Anatomica AB, 2007) after a 196-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Jan 22, 2014
- Review
- 196 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033961 (2004). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK033961 Altius Oct SystemInterpore Cross Intl. · 2004
- 1 generation backK061943 Anatomica Posterior Cervical Fixation SystemAnatomica AB · 2007
- This deviceK132122 Kestrel Posterior Cervical Spine SystemOmni Surgical, LLC Dba Spine360 · 2014
- Descendant · cites it directly · 0 of its ownK181350 ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033961 | Altius Oct System | Interpore Cross Intl. | 2004 | — |
| −1 | K061943 | Anatomica Posterior Cervical Fixation System | Anatomica AB | 2007 | — |
| 0 (this device) | K132122 | Kestrel Posterior Cervical Spine System | Omni Surgical, LLC Dba Spine360 | 2014 | — |
| +1 | K181350 | ASTRA-OCT Spine System | Spinecraft, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K061943 | Anatomica Posterior Cervical Fixation SystemSummary page 1…DE NAME Kestrel Posterior Cervical Fixation System PREDICATE DEVICE Anatoniica Posterior Cervical Fixation System K061943 CLASS OF DEVICE Class 11… | 2007 |
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 |
|---|---|---|---|
| K181350 | ASTRA-OCT Spine System | 2018 | 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 10 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K181350 (Spinecraft, LLC, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Kestrel Posterior Cervical Fixation System is intended to promote fiusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications: * Degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies *…
Read the full statement (145 words)
The Kestrel Posterior Cervical Fixation System is intended to promote fiusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3). The system is intended for posterior, cervical, non-pedicle fixation, or for posterior, noncervical pedicle fixation for the following indications:
* Degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
* Spondylolisthesis
* Trauma (i.e fracture or dislocation)
* Spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and /or lordosis)
* Tumor
* Pseudoarthrosis
* Failed previous fusion
Occipital bone screws are limited to occipital fixation only. Pedicle screws are limited to placement in the upper thoracic spine (TI -T3), when anchoring the OCT construct only. Pedicle screws are not intended to be placed in the cervical spine. Hooks and wires (not pedicle screws) are used to achieve cervical fission for the occipital/cervical loop.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132122 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132122: Kestrel Posterior Cervical Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132122
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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