510(k) · Cleared
Recalled · Class II · 2012Synthes Vectra-T 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 Sep 9, 2005 as substantially equivalent to K971883 (Synthes (Usa), 1997) and 2 other predicates after a 79-day review. Its family tree reaches back 3 generations to 2003. 49 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 9, 2005
- Review
- 79 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K031276 (2003). 7 ancestors in all, the oldest K926453 (1993). 49 later devices descend from it, 5 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 deviceK051665 Synthes Vectra-T SystemSynthes Spine · 2005
- 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 · 3 generations on · 24 of its ownK131429 Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013
- Descendant · 4 generations on · 23 of its ownK142269 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015
- Descendant · 5 generations on · 16 of its ownK172489 Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- 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
- K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2013 · 3 generations on24descendants
- K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2015 · 4 generations on23descendants
- K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC · 2017 · 5 generations on16descendants
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) | K051665 | Synthes Vectra-T System | Synthes Spine | 2005 | — |
| +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 | — |
| +3 | K131429 | Reliance Cervical Ibf System | Reliance Medical Systems, LLC | 2013 | — |
| +4 | K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015 | — |
| +5 | K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSummary page 1…Instrumentation Device Product Code KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis and Classification: Class II Substantially K971883 - Synthes CSLP-SS (Cervical Spine Locking Plate - Equivalent Devices: Small Stature), cleared October 16, 1997… | 1997 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 1…ly K971883 - Synthes CSLP-SS (Cervical Spine Locking Plate - Equivalent Devices: Small Stature), cleared October 16, 1997 K030866 - CSLP (added DDD indication), cleared April 18, 2003 K050451 - Synthes Vectra System, cleared March… | 2003 |
| * | K050451 | Synthes Vectra SystemSummary page 1…es: Small Stature), cleared October 16, 1997 K030866 - CSLP (added DDD indication), cleared April 18, 2003 K050451 - Synthes Vectra System, cleared March 24, 2005 Device Description: The Synthes Vectra-T System consists of one-level to… | 2005 |
What descends from it? (49)
See all 495 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112068 | Synthes Zero-P Variable Angle (VA) | 2011 | 33 |
| K121049 | Unify Dynamic Anterior Cervical Plate System | 2012 | 10 |
| K111135 | Pyrenees Cervical Plate System (Translational Plates) | 2011 | 1 |
| K240592 | Wolff's Law Anterior Cervical Plate System | 2024 | 0 |
| K073500 | Active Anterior Cervical Plate System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 3 companies; a new generation was cleared every 7 months on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K112068 (Synthes Spine Co.Lp, 2011) has gone furthest, with 33 descendants of its own.
- 15 other devices also cite its predicate K971883.
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-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).
Synthes Vectra-T System is indicated 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/K051665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051665: Synthes Vectra-T System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051665
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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