510(k) · Cleared
ClearedSynthes Anterior Tension Band (Atb) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 13, 2002 after an 83-day review. The FDA summary names no predicate by number. 1 of the 582 devices in its family, counting itself, has a Class I recall. 581 later devices descend from it.
- Decided
- Nov 13, 2002
- Review
- 83 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
581 later devices descend from it, 15 citing it directly. 1 of the 582 devices in this family, counting this one, has a Class I recall.
- This deviceK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
- Descendant · cites it directly · 477 of its ownK063158 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
Showing 5 of 581 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 581 · See all- K063158Synthes Antegra SystemSynthes Spine Co.Lp · 2006 · cites it directly477descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022791 | Synthes Anterior Tension Band (Atb) System | Synthes (Usa) | 2002 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 13 | 0 |
| 2017 | 21 | 0 |
| 2018 | 26 | 0 |
| 2019 | 34 | 0 |
| 2020 | 55 | 0 |
| 2021 | 49 | 1 |
| 2022 | 65 | 0 |
| 2023 | 74 | 0 |
| 2024 | 87 | 0 |
| 2025 | 68 | 0 |
| 2026 | 63 | 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?
The FDA summary names no predicate by number.
What descends from it? (581)
See all 58115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063158 | Synthes Antegra System | 2006 | 477 |
| K081568 | Antegra-T | 2008 | 472 |
| K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | 2006 | 165 |
| K070922 | Modification to Spinal Usa VBR System | 2007 | 161 |
| K082187 | Biomet Anterior Lumbar Plate | 2008 | 126 |
| K121791 | Zou Anterior Lumbar Plate System | 2012 | 113 |
| K073437 | Thor Anterior Plating System | 2008 | 102 |
| K062836 | Citadel Anterior Lumbar Plate System | 2006 | 50 |
| K171538 | Cure™ Lumbar Plate System | 2017 | 19 |
| K124034 | Mectalif Anterior | 2013 | 11 |
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?
- Of its descendants, K063158 (Synthes Spine Co.Lp, 2006) has gone furthest, with 477 descendants of its own.
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?
The Synthes Anterior Tension Band System is indicated 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. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S 1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of…
Read the full statement (103 words)
The Synthes Anterior Tension Band System is indicated 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. This system is indicated in the treatment of lumbar and lumbosacral (L1 - S 1) spine instability as a result of 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, or a failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022791: Synthes Anterior Tension Band (Atb) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022791
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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