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 · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 28, 2007 as substantially equivalent to K011067 (Medtronic Sofamor Danek, Inc., 2001) and 6 other predicates after a 30-day review. Its family tree reaches back 4 generations to 2004. 10 later devices descend from it.
- Decided
- Sep 28, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K040583 (2004). 20 ancestors in all, the oldest K981676 (1999). 10 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 1 generation backK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- This deviceK072429 Modification to TSRH Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 8 of its ownK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
- Descendant · cites it directly · 7 of its ownK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
- Descendant · 2 generations on · 5 of its ownK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
- Descendant · cites it directly · 5 of its ownK110896 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
- Descendant · 2 generations on · 4 of its ownK152131 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009 · cites it directly8descendants
- K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010 · cites it directly7descendants
- K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013 · 2 generations on5descendants
- K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012 · cites it directly5descendants
- K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −1 | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| 0 (this device) | K072429 | Modification to TSRH Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K081978 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2009 | — |
| +1 | K101112 | Reliance Spinal Screw System | Reliance Medical Systems | 2010 | — |
| +2 | K123521 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2013 | — |
| +1 | K110896 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2012 | — |
| +2 | K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 NKB? 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? (7)
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 |
|---|---|---|---|
| * | K011067 | Modification to TSRH Spinal System | 2001 |
| * | K020699 | TSRH Spinal SystemSummary page 2…k analysis, was provided which demonstrated the subject screws to be substantially equivalent to predicate TSRH® components previously cleared in KO1 1067, K020699, K021170, K022778, K041282, K052054, and K062807. © 2007 Medtronic Sofamor Danek… | 2002 |
| * | K021170 | TSRH Spinal SystemSummary page 2…s, was provided which demonstrated the subject screws to be substantially equivalent to predicate TSRH® components previously cleared in KO1 1067, K020699, K021170, K022778, K041282, K052054, and K062807. © 2007 Medtronic Sofamor Danek… | 2002 |
| * | K022778 | Modification to TSRH Spinal SystemSummary page 2…ovided which demonstrated the subject screws to be substantially equivalent to predicate TSRH® components previously cleared in KO1 1067, K020699, K021170, K022778, K041282, K052054, and K062807. © 2007 Medtronic Sofamor Danek… | 2002 |
| * | K041282 | Modification to TSRH Spinal SystemSummary page 2…ich demonstrated the subject screws to be substantially equivalent to predicate TSRH® components previously cleared in KO1 1067, K020699, K021170, K022778, K041282, K052054, and K062807. © 2007 Medtronic Sofamor Danek… | 2004 |
| * | K052054 | TSRH Spinal SystemSummary page 2…strated the subject screws to be substantially equivalent to predicate TSRH® components previously cleared in KO1 1067, K020699, K021170, K022778, K041282, K052054, and K062807. © 2007 Medtronic Sofamor Danek… | 2005 |
| * | K062807 | TSRH Spinal SystemSummary page 2…ubject screws to be substantially equivalent to predicate TSRH® components previously cleared in KO1 1067, K020699, K021170, K022778, K041282, K052054, and K062807. © 2007 Medtronic Sofamor Danek… | 2006 |
What descends from it? (10)
4 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K081978 (Reliance Medical Systems, LLC, 2009) has gone furthest, with 8 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. 2007, this device’s year, is highlighted.
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 of 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 (250 words)
When used as a pedicle screw fixation system of 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) vertebral 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, andjor (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/K072429 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072429: Modification to TSRH Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072429
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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