510(k) · Cleared
ClearedBoomerang™ Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 1, 2019 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 4 other predicates after an 85-day review. Its family tree reaches back 5 generations to 2003. 4 later devices descend from it.
- Decided
- May 1, 2019
- Review
- 85 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K031276 (2003). 21 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- 4 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- 3 generations backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
- 2 generations backK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
- 1 generation backK143576 Exactech AmbassadorExactech, Inc. · 2015 · Recalled
- This deviceK190227 Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
- Descendant · cites it directly · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- Descendant · 3 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243369 Cervical Plating SystemLife Spine, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · cites it directly2descendants
- K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 2 generations on1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 3 generations on0descendants
- K243369Cervical Plating SystemLife Spine, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| −4 | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| −3 | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | 3 |
| −2 | K071667 | Synthes Vectra-One System | Synthes Spine | 2007 | 3 |
| −1 | K143576 | Exactech Ambassador | Exactech, Inc. | 2015 | 1 |
| 0 (this device) | K190227 | Boomerang™ Anterior Cervical Plate System | Choicespine, LP | 2019 | — |
| +1 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +2 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| +3 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
| +1 | K243369 | Cervical Plating System | Life Spine, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 5…Attachment 4 further demonstrate substantial equivalence to the predicate devices. Predicate Devices: Primary predicate: DePuy Synthes Anterior CSLP System (K030866) Additional Predicates: ChoiceSpine AmbassadorTM (K143576)… | 2003 |
| * | K143576 | Exactech AmbassadorSummary page 5…es. Predicate Devices: Primary predicate: DePuy Synthes Anterior CSLP System (K030866) Additional Predicates: ChoiceSpine AmbassadorTM (K143576) Eurosurgical, SA ORIA Zenith (K030500)… | 2015 |
| * | K030500 | Oria ZenithSummary page 5…(K030866) Additional Predicates: ChoiceSpine AmbassadorTM (K143576) Eurosurgical, SA ORIA Zenith (K030500) DePuy Motech AcroMed – DOCTM Ventral Cervical… | 2003 |
| * | K982443 | Doc Ventral Cervical Stabilization SystemSummary page 5…K030500) DePuy Motech AcroMed – DOCTM Ventral Cervical Stablization System (K982443) Stryker Spine – Aviator Plate (K083562) | 1998 |
| * | K083562 | Stryker Spine Nulock Anterior Cervical Plating SystemSummary page 5…ntral Cervical Stablization System (K982443) Stryker Spine – Aviator Plate (K083562) | 2009 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 21 ancestors have a recall of any class.
- Of its descendants, K243015 (Kyocera Medical Technologies, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 41 other devices also cite its predicate K030866.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The ChoiceSpine BoomerangTM Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
WARNING: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190227: Boomerang™ Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190227
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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