510(k) · Cleared
Recalled · Class II · 2014Synthes Vectra System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine Co.Lp · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 24, 2005 as substantially equivalent to K033844 (Synthes (Usa), 2004) after a 30-day review. Its family tree reaches back 2 generations to 2003. 84 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 24, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031276 (2003). 84 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- 1 generation backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- This deviceK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005
- Descendant · cites it directly · 49 of its ownK051665 Synthes Vectra-T SystemSynthes Spine · 2005 · Recalled
- Descendant · cites it directly · 33 of its ownK112068 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · Recalled
- Descendant · 2 generations on · 30 of its ownK121852 Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012
- Descendant · cites it directly · 26 of its ownK071667 Synthes Vectra-One SystemSynthes Spine · 2007 · Recalled
- Descendant · 3 generations on · 24 of its ownK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K051665Synthes Vectra-T SystemSynthes Spine · 2005 · cites it directly49descendants
- K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2011 · cites it directly33descendants
- K121852Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp · 2012 · 2 generations on30descendants
- K071667Synthes Vectra-One SystemSynthes Spine · 2007 · cites it directly26descendants
- K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| −1 | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| 0 (this device) | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | — |
| +1 | K051665 | Synthes Vectra-T System | Synthes Spine | 2005 | 2 |
| +1 | K112068 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2011 | 1 |
| +2 | K121852 | Synthes Zero-P Variable Angle (VA) | Synthes Spine Co.Lp | 2012 | — |
| +1 | K071667 | Synthes Vectra-One System | Synthes Spine | 2007 | 3 |
| +3 | K131429 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K033844 | Synthes Anterior Cervical Compression SystemSummary page 1…trumentation Device Product Code KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis and Classification: Class II Substantially Synthes ACCS - K033844 Equivalent Devices: Device Description: The Synthes Vectra System consists of one-level to four-level p… | 2004 |
What descends from it? (84)
See all 848 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051665 | Synthes Vectra-T System | 2005 | 49 |
| K112068 | Synthes Zero-P Variable Angle (VA) | 2011 | 33 |
| K071667 | Synthes Vectra-One System | 2007 | 26 |
| K180022 | Athena Cervical Plate System | 2018 | 2 |
| K183409 | Athena II Cervical Plate System | 2019 | 1 |
| K061147 | Opteryx Anterior Cervical Plate System | 2006 | 1 |
| K171797 | TRYPTIK2 C-Plate Anterior Cervical Plate System | 2018 | 0 |
| K140361 | Meta-C Cervical Plate | 2014 | 0 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051665 (Synthes Spine, 2005) has gone furthest, with 49 descendants of its own.
- 1 other device also cites its predicate K033844.
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.
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?
Synthes VECTRA System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Synthes VECTRA System is ihdicated for the following:
* 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
* Pseudoarthrosis
* Deformity (i.e., scoliosis, kyphosis, and/or lordosis)
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/K050451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050451: Synthes Vectra System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050451
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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