510(k) · Cleared
ClearedModification to Tenor Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 28, 2002 after a 54-day review. The FDA summary names no predicate by number. 27 later devices descend from it.
- Decided
- Aug 28, 2002
- Review
- 54 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 2 citing it directly.
- This deviceK022191 Modification to Tenor Spinal SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · cites it directly · 20 of its ownK221646 CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion…Medtronic Sofamor Danek USA, Inc. · 2022
- Descendant · 2 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 3 generations on · 5 of its ownK233951 CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set…Medtronic Sofamor Danek USA, Inc. · 2024
- Descendant · 3 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
- Descendant · cites it directly · 5 of its ownK071921 Innovasis Excella Spinal System, Excella-M (Monoaxial Screws)…Innovasis, Inc. · 2007
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc. · 2022 · cites it directly20descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 2 generations on17descendants
- K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc. · 2024 · 3 generations on5descendants
- K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 3 generations on5descendants
- K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc. · 2007 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022191 | Modification to Tenor Spinal System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +1 | K221646 | CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD… | Medtronic Sofamor Danek USA, Inc. | 2022 | — |
| +2 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +3 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | Medtronic Sofamor Danek USA, Inc. | 2024 | — |
| +3 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
| +1 | K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P… | Innovasis, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 9 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (27)
See all 272 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K221646 (Medtronic Sofamor Danek USA, Inc., 2022) has gone furthest, with 20 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TENORm Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S 1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be fiom L3 to sacrum); and/or (d) who are having the device removed…
Read the full statement (187 words)
The TENORm Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S 1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be fiom L3 to sacrum); and/or (d) who are having the device removed after the development of a solid fusion mass.
TENORm Plates are intended for the L5-S 1 pedicle screw indication described above only.
The TENORTMSpinal System, when used as a non-pedicle screw fixation system, is intended for the following indications: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) pseudarthrosis, 3) stenosis, 4) spondylolisthesis, 5) spinal deformities: scoliosis, kyphosis, lordosis, 6) fracture, 7) unsuccessful previous attempts at spinal fusion, and/or 8) tumor resection. When used for posterior non-pedicle screw fixation, the TENORTMSpinal System is intended for thoracic, lumbar, and sacral (T 1-Sacrum) fixation only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022191: Modification to Tenor Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022191
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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