510(k) · Cleared
Recalled · 2007TSRH 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 Aug 31, 2005 as substantially equivalent to K042210 (Medtronic Sofamor Danek, 2004) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 1999. 1 of the 670 devices in its family, counting itself, has a Class I recall. 665 later devices descend from it. It has been recalled once.
- Decided
- Aug 31, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981676 (1999). 4 ancestors in all. 665 later devices descend from it, 3 citing it directly. 1 of the 670 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 2 generations backK041030 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK042210 MSD Silo Spinal SystemMedtronic Sofamor Danek · 2004 · Recalled
- This deviceK052144 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 663 of its ownK090390 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 3 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- Descendant · 3 generations on · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 665 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 665 · See all- K090390CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · cites it directly663descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 2 generations on656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 3 generations on598descendants
- K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 3 generations on597descendants
- K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 3 generations on597descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −2 | K041030 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K042210 | MSD Silo Spinal System | Medtronic Sofamor Danek | 2004 | 1 |
| 0 (this device) | K052144 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K090390 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +3 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +3 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| +3 | K112555 | CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 14 | 0 |
| 2013 | 24 | 0 |
| 2014 | 34 | 0 |
| 2015 | 37 | 0 |
| 2016 | 39 | 0 |
| 2017 | 44 | 0 |
| 2018 | 48 | 0 |
| 2019 | 38 | 0 |
| 2020 | 46 | 0 |
| 2021 | 45 | 1 |
| 2022 | 48 | 0 |
| 2023 | 67 | 0 |
| 2024 | 60 | 0 |
| 2025 | 57 | 0 |
| 2026 | 54 | 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? (2)
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 |
|---|---|---|---|
| * | K042210 | MSD Silo Spinal SystemSummary page 2…components were demonstrated to be substantially equivalent to the MSD SiLo M Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K042210, as well as to CD HORIZON® Spinal System SiLo TM… | 2004 |
| * | K041030 | Modification to CD Horizon Spinal SystemSummary page 2…s to CD HORIZON® Spinal System SiLo TM components cleared in K041030. A risk analysis was provided in support of this application. The labeling for this device is identical to that cleared by the… | 2004 |
What descends from it? (665)
See all 6653 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 24, 2007 | Not classified | Z-0074-2008 | Device Design | Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws. |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K090390 (Medtronic Sofamor Danek, 2009) has gone furthest, with 663 descendants of its own.
- 1 other device also cites its predicate K042210.
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-SI) 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 (13 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/K052144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052144: TSRH 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/K052144
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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