510(k) · Cleared
ClearedKaneda Anterior Scoliosis System Kass
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acromed Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 5, 1998 after a 76-day review. The FDA summary names its predicate without a number. 1 of the 608 devices in its family, counting itself, has a Class I recall. 607 later devices descend from it.
- Decided
- Mar 5, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
607 later devices descend from it, 7 citing it directly. 1 of the 608 devices in this family, counting this one, has a Class I recall.
- This deviceK974757 Kaneda Anterior Scoliosis System KassAcromed Corp. · 1998
- Descendant · cites it directly · 601 of its ownK012916 Frontier Anterior Scoliosis SystemDepuy Acromed, Inc. · 2001
- Descendant · cites it directly · 582 of its ownK071668 Orthobiom Spinal SystemParadigm Spine · 2008
- Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 3 generations on · 269 of its ownK110070 TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · 3 generations on · 261 of its ownK111457 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011
Showing 5 of 607 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 607 · See all- K012916Frontier Anterior Scoliosis SystemDepuy Acromed, Inc. · 2001 · cites it directly601descendants
- K071668Orthobiom Spinal SystemParadigm Spine · 2008 · cites it directly582descendants
- K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
- K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 3 generations on269descendants
- K111457CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011 · 3 generations on261descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974757 | Kaneda Anterior Scoliosis System Kass | Acromed Corp. | 1998 | — |
| +1 | K012916 | Frontier Anterior Scoliosis System | Depuy Acromed, Inc. | 2001 | — |
| +1 | K071668 | Orthobiom Spinal System | Paradigm Spine | 2008 | — |
| +2 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +3 | K110070 | TSRH Spinal System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +3 | K111457 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 15 | 0 |
| 2013 | 25 | 0 |
| 2014 | 32 | 0 |
| 2015 | 43 | 0 |
| 2016 | 36 | 0 |
| 2017 | 41 | 0 |
| 2018 | 41 | 0 |
| 2019 | 30 | 0 |
| 2020 | 36 | 0 |
| 2021 | 32 | 1 |
| 2022 | 42 | 0 |
| 2023 | 60 | 0 |
| 2024 | 60 | 0 |
| 2025 | 51 | 0 |
| 2026 | 49 | 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 |
|---|---|---|---|
| * | — | Kaneda SR Anterior Spinal System Named without a submission number |
What descends from it? (607)
See all 6077 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012916 | Frontier Anterior Scoliosis System | 2001 | 601 |
| K071668 | Orthobiom Spinal System | 2008 | 582 |
| K024125 | Halm Zielke Instrumentation System | 2003 | 1 |
| K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine… | 2019 | 0 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
| K071074 | Mykres Spinal System | 2008 | 0 |
| K030667 | Encore Anterior Spinal Staple System | 2003 | 0 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K012916 (Depuy Acromed, Inc., 2001) has gone furthest, with 601 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 Kaneda Anterior Scoliosis System is intended for use in: 1. Idiopathic scoliosis. 2. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. 4. Neuromuscular scoliosis/Kyphoscoliosis 5. Spinal fractures (acute reduction or late deformity). 6. Revision surgery. 7.…
Read the full statement (165 words)
The Kaneda Anterior Scoliosis System is intended for use in:
1. Idiopathic scoliosis.
2. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
4. Neuromuscular scoliosis/Kyphoscoliosis
5. Spinal fractures (acute reduction or late deformity).
6. Revision surgery.
7. Tumor.
In addition, the Kaneda Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include:
1. Collapsing and unstable paralytic deformity.
2. Progressively increasing scoliosis.
3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
4. Inability to maintain sitting balance, necessitating the use of hands.
5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
The intended levels for treatment with the Kaneda Anterior Scoliosis System, are T4 to L4.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974757: Kaneda Anterior Scoliosis System Kass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974757
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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