510(k) · Cleared
Recalled · Class II · 2014Synthes Vectra-One System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 30, 2007 as substantially equivalent to K926453 (Synthes (Usa), 1993) and 3 other predicates after a 164-day review. Its family tree reaches back 3 generations to 2003. 26 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 30, 2007
- Review
- 164 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 3 generations to K031276 (2003). 7 ancestors in all, the oldest K792352 (1979). 26 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- 2 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- 1 generation backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
- This deviceK071667 Synthes Vectra-One SystemSynthes Spine · 2007
- Descendant · cites it directly · 15 of its ownK130030 Zavation Cervical Plate SystemZavation, LLC · 2013
- Descendant · cites it directly · 7 of its ownK143576 Exactech AmbassadorExactech, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK172104 Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK190227 Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019
- Descendant · 3 generations on · 4 of its ownK182473 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System…K2m, Inc. · 2018
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K130030Zavation Cervical Plate SystemZavation, LLC · 2013 · cites it directly15descendants
- K143576Exactech AmbassadorExactech, Inc. · 2015 · cites it directly7descendants
- K172104Ozark (tm) Cervical Plate SystemK2m, Inc. · 2017 · 2 generations on5descendants
- K190227Boomerang™ Anterior Cervical Plate SystemChoicespine, LP · 2019 · 2 generations on4descendants
- K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc. · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| −2 | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| −1 | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | 3 |
| 0 (this device) | K071667 | Synthes Vectra-One System | Synthes Spine | 2007 | — |
| +1 | K130030 | Zavation Cervical Plate System | Zavation, LLC | 2013 | — |
| +1 | K143576 | Exactech Ambassador | Exactech, Inc. | 2015 | 1 |
| +2 | K172104 | Ozark (tm) Cervical Plate System | K2m, Inc. | 2017 | — |
| +2 | K190227 | Boomerang™ Anterior Cervical Plate System | Choicespine, LP | 2019 | — |
| +3 | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK… | K2m, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSummary page 1…Orthopaedic and Rehabilitation Devices Panel Product Code KWQ Synthes Anterior Cervical Vertebra Plates (K926453) Predicates: Synthes Vectra System (K}050451) Synthes Cervical Vertebrae Plates (K792352)… | 1993 |
| * | K050451 | Synthes Vectra SystemSummary page 1…a bone) to be used. The Vectra-One System uses the identical and compatible bone-screws from the Synthes Vectra System (K05045 1). Furthermore, the integrated one-step blocking mechanism is identical to the mechanism from the… | 2005 |
| * | K792352 | Synthes Cervical Vertabrae PlatesSummary page 1…Synthes Anterior Cervical Vertebra Plates (K926453) Predicates: Synthes Vectra System (K}050451) Synthes Cervical Vertebrae Plates (K792352) DePuy Spine UniPlate Anterior Cervical Plate System (K042544) Device The Synthes Vec… | 1979 |
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 1…ctra System (K}050451) Synthes Cervical Vertebrae Plates (K792352) DePuy Spine UniPlate Anterior Cervical Plate System (K042544) Device The Synthes Vectra-One System consists of titanium plates with an integrated Description:… | 2004 |
What descends from it? (26)
See all 264 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2014 | Class II | Z-2674-2014 | Employee error | DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior Cervical Plate Family of Systems. The Vectra Systems are intended for anterior… |
| Aug 6, 2012 | Class II | Z-0782-2013 | Component design/selection | Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. |
| Aug 6, 2012 | Class II | Z-0781-2013 | Component design/selection | Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K130030 (Zavation, LLC, 2013) has gone furthest, with 15 descendants of its own.
- 14 other devices also cite its predicate K926453.
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. 2007, 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 Vectra-One System is intended for anterior plate and screw fixation of the cervical spine (C2-C7) 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., fractures or dislocations)
* Spinal stenosis
* Tumors (primary and metastatic)
· Failed previous fusions
* Pseudarthrosis
· Deformity (i.e., kyphosis, lordosis and/or scoliosis)
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/K071667 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071667: Synthes Vectra-One System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071667
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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