510(k) · Cleared
ClearedModification to TSRH Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 25, 2003 after a 28-day review. The FDA summary names its predicate without a number. 1 of the 629 devices in its family, counting itself, has a Class I recall. 628 later devices descend from it.
- Decided
- Feb 25, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
628 later devices descend from it, 4 citing it directly. 1 of the 629 devices in this family, counting this one, has a Class I recall.
- This deviceK030285 Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2003
- Descendant · cites it directly · 625 of its ownK072317 Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 614 of its ownK081080 TSRH Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · 3 generations on · 606 of its ownK091797 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 4 generations on · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 5 generations on · 596 of its ownK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
Showing 5 of 628 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 628 · See all- K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · cites it directly625descendants
- K081080TSRH Spinal SystemMedtronic Sofamor Danek · 2008 · 2 generations on614descendants
- K091797TSRH Spinal SystemMedtronic Sofamor Danek · 2010 · 3 generations on606descendants
- K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 4 generations on597descendants
- K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 5 generations on596descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030285 | Modification to TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2003 | — |
| +1 | K072317 | Modification to:TSRH Spinal System | Medtronic Sofamor Danek USA, Inc. | 2007 | 4 |
| +2 | K081080 | TSRH Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +3 | K091797 | TSRH Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +4 | K112555 | CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 24 | 0 |
| 2014 | 31 | 0 |
| 2015 | 36 | 0 |
| 2016 | 36 | 0 |
| 2017 | 42 | 0 |
| 2018 | 42 | 0 |
| 2019 | 35 | 0 |
| 2020 | 44 | 0 |
| 2021 | 44 | 1 |
| 2022 | 45 | 0 |
| 2023 | 62 | 0 |
| 2024 | 58 | 0 |
| 2025 | 55 | 0 |
| 2026 | 53 | 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | — | TSRH-3D Spinal System Named without a submission number |
What descends from it? (628)
See all 6284 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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K072317 (Medtronic Sofamor Danek USA, Inc., 2007) has gone furthest, with 625 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation…
Read the full statement (249 words)
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal 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) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030285 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030285: Modification to TSRH Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030285
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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