510(k) · Cleared
ClearedSynthes Antegra 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 Nov 14, 2006 as substantially equivalent to K022791 (Synthes (Usa), 2002) after a 28-day review. Its family tree reaches back 1 generation to 2002. 1 of the 479 devices in its family, counting itself, has a Class I recall. 477 later devices descend from it.
- Decided
- Nov 14, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022791 (2002). 477 later devices descend from it, 3 citing it directly. 1 of the 479 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
- This deviceK063158 Synthes Antegra SystemSynthes Spine Co.Lp · 2006
- Descendant · cites it directly · 472 of its ownK081568 Antegra-TSynthes Spine Co.Lp · 2008
- Descendant · 2 generations on · 469 of its ownK121815 Nuvasive Sage Lateral Plate SystemNuvasive, Inc. · 2012
- Descendant · 3 generations on · 466 of its ownK131723 Coroent Single Tab SystemNuvasive, Inc. · 2013
- Descendant · 4 generations on · 465 of its ownK140479 Coroent XL-F SystemNu Vasive, Incorporated · 2014
- Descendant · 4 generations on · 396 of its ownK160051 NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016
Showing 5 of 477 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 477 · See all- K081568Antegra-TSynthes Spine Co.Lp · 2008 · cites it directly472descendants
- K121815Nuvasive Sage Lateral Plate SystemNuvasive, Inc. · 2012 · 2 generations on469descendants
- K131723Coroent Single Tab SystemNuvasive, Inc. · 2013 · 3 generations on466descendants
- K140479Coroent XL-F SystemNu Vasive, Incorporated · 2014 · 4 generations on465descendants
- K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated · 2016 · 4 generations on396descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022791 | Synthes Anterior Tension Band (Atb) System | Synthes (Usa) | 2002 | — |
| 0 (this device) | K063158 | Synthes Antegra System | Synthes Spine Co.Lp | 2006 | — |
| +1 | K081568 | Antegra-T | Synthes Spine Co.Lp | 2008 | — |
| +2 | K121815 | Nuvasive Sage Lateral Plate System | Nuvasive, Inc. | 2012 | — |
| +3 | K131723 | Coroent Single Tab System | Nuvasive, Inc. | 2013 | — |
| +4 | K140479 | Coroent XL-F System | Nu Vasive, Incorporated | 2014 | — |
| +4 | K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 11 | 0 |
| 2017 | 17 | 0 |
| 2018 | 20 | 0 |
| 2019 | 24 | 0 |
| 2020 | 44 | 0 |
| 2021 | 43 | 1 |
| 2022 | 52 | 0 |
| 2023 | 59 | 0 |
| 2024 | 81 | 0 |
| 2025 | 64 | 0 |
| 2026 | 54 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K022791 | Synthes Anterior Tension Band (Atb) SystemSummary page 1…Orthopaedic and Rehabilitation Devices Panel Product Code KWQ Predicate Device: Synthes Anterior Tension Band (ATB) System - K022791 Device Description: The Synthes Antegra System consists of lumbar and sacral plates (o… | 2002 |
What descends from it? (477)
See all 4773 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Antegra System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. Synthes Antegra System is indicated in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of the following: * Fracture (including dislocation and subluxation) * Tumor * Degenerative Disc Disease (defined as back…
Read the full statement (131 words)
Synthes Antegra System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.
Synthes Antegra System is indicated in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of the following:
* Fracture (including dislocation and subluxation)
* Tumor
* Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
* Pseudoarthrosis
* Spondylolysis
* Spondylolisthesis
* Scoliosis
* Lordotic deformities of the spine
* Spinal stenosis
* Failed previous spine surgery.
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/K063158 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063158: Synthes Antegra System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063158
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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