510(k) · Cleared
ClearedTSRH 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 16, 2005 as substantially equivalent to K050282 (Medtronic Sofamor Danek, 2005) and 3 other predicates after an 18-day review. Its family tree reaches back 3 generations to 2004. 1 of the 800 devices in its family, counting itself, has a Class I recall. 786 later devices descend from it.
- Decided
- Aug 16, 2005
- Review
- 18 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K040583 (2004). 13 ancestors in all, the oldest K981676 (1999). 786 later devices descend from it, 8 citing it directly. 1 of the 800 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- This deviceK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 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 · cites it directly · 606 of its ownK091797 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 2 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
Showing 5 of 786 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 786 · See all- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · cites it directly656descendants
- 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 · cites it directly606descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 2 generations on598descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| 0 (this device) | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +1 | K072317 | Modification to:TSRH Spinal System | Medtronic Sofamor Danek USA, Inc. | 2007 | 4 |
| +2 | K081080 | TSRH Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +1 | K091797 | TSRH Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +2 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 11 | 0 |
| 2012 | 21 | 0 |
| 2013 | 39 | 0 |
| 2014 | 42 | 0 |
| 2015 | 49 | 0 |
| 2016 | 46 | 0 |
| 2017 | 53 | 0 |
| 2018 | 57 | 0 |
| 2019 | 43 | 0 |
| 2020 | 55 | 0 |
| 2021 | 48 | 1 |
| 2022 | 53 | 0 |
| 2023 | 72 | 0 |
| 2024 | 61 | 0 |
| 2025 | 58 | 0 |
| 2026 | 59 | 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? (4)
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 |
|---|---|---|---|
| * | K050282 | Modification to TSRH Spinal SystemSummary page 2…strated to be substantially equivalent to TSRI-1 Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA inl K050282 (02/18/05), as wveil as to CD HORIZON® Spinal System components cleared in K042025 (SE 08/25/04), COLORADO I®~… | 2005 |
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 2…nts manufactured by Medtronic Sofamor Danek and cleared by the FDA inl K050282 (02/18/05), as wveil as to CD HORIZON® Spinal System components cleared in K042025 (SE 08/25/04), COLORADO I®~ Spinal System components cleared in K991091 (SE 05/… | 2004 |
| * | K991031 | Colorado II Spinal System Our reading of the summary gave K991091, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “COLORADO I® Spinal System”. | 2000 |
| * | K032560 | Arrowhead Spinal SystemSummary page 2…LORADO I®~ Spinal System components cleared in K991091 (SE 05/10/00) and ARROWHEAD® Spinal System components cleared in K032560 (SE 03/09/04). Mechanical test results were provided in support of this application. The labeling for this device is… | 2004 |
What descends from it? (786)
See all 7868 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091974 | Modification to CD Horizon Spinal System | 2009 | 656 |
| K072317 | Modification to:TSRH Spinal System | 2007 | 625 |
| K091797 | TSRH Spinal System | 2010 | 606 |
| K093058 | TSRH Spinal System | 2009 | 478 |
| K122433 | CD Horizon Spinal System | 2012 | 39 |
| K072429 | Modification to TSRH Spinal System | 2007 | 10 |
| K090740 | Modification to: TSRH Spinal System | 2009 | 1 |
| K101772 | TSRH (R) Spinal System | 2010 | 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?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 3 months on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K091974 (Medtronic Sofamor Danek USA, Inc., 2009) has gone furthest, with 656 descendants of its own.
- 1 other device also cites its predicate K050282.
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 TSRII® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) 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 TSRHt® 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/K052054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052054: 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/K052054
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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