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 Apr 30, 2010 as substantially equivalent to K081080 (Medtronic Sofamor Danek, 2008) and 2 other predicates after a 317-day review. Its family tree reaches back 6 generations to 2004. 1 of the 631 devices in its family, counting itself, has a Class I recall. 606 later devices descend from it.
- Decided
- Apr 30, 2010
- Review
- 317 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K040583 (2004). 24 ancestors in all, the oldest K982990 (1998). 606 later devices descend from it, 3 citing it directly. 1 of the 631 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 3 generations backK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK072317 Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · Recalled
- 1 generation backK081080 TSRH Spinal SystemMedtronic Sofamor Danek · 2008
- This deviceK091797 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 2 generations on · 596 of its ownK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 357 of its ownK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 3 generations on · 286 of its ownK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- Descendant · 3 generations on · 244 of its ownK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
Showing 5 of 606 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 606 · See all- K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly597descendants
- K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on596descendants
- K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 3 generations on357descendants
- K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014 · 3 generations on286descendants
- K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 3 generations on244descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −3 | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K072317 | Modification to:TSRH Spinal System | Medtronic Sofamor Danek USA, Inc. | 2007 | 4 |
| −1 | K081080 | TSRH Spinal System | Medtronic Sofamor Danek | 2008 | — |
| 0 (this device) | K091797 | TSRH Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K112555 | CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +2 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| +3 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +3 | K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014 | — |
| +3 | K130646 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 22 | 0 |
| 2014 | 29 | 0 |
| 2015 | 35 | 0 |
| 2016 | 33 | 0 |
| 2017 | 42 | 0 |
| 2018 | 42 | 0 |
| 2019 | 34 | 0 |
| 2020 | 44 | 0 |
| 2021 | 43 | 1 |
| 2022 | 45 | 0 |
| 2023 | 62 | 0 |
| 2024 | 57 | 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? (3)
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 |
|---|---|---|---|
| * | K081080 | TSRH Spinal SystemSummary page 2…materials and indications for use of the TSRH®~ Spinal System are substantially equivalent to predicate TSRH® Spinal System components previously cleared in K081080 (S.E. 11/21/2008), K052054 (S.E. 08/16/2005) and predicate CD HORIZON® Spinal System components cleared in K043151 (S… | 2008 |
| * | K052054 | TSRH Spinal SystemSummary page 2…for use of the TSRH®~ Spinal System are substantially equivalent to predicate TSRH® Spinal System components previously cleared in K081080 (S.E. 11/21/2008), K052054 (S.E. 08/16/2005) and predicate CD HORIZON® Spinal System components cleared in K043151 (S.E. 02/01/2005). === Page… | 2005 |
| * | K043151 | Modification to: CD Horizon Spinal SystemSummary page 2…tem components previously cleared in K081080 (S.E. 11/21/2008), K052054 (S.E. 08/16/2005) and predicate CD HORIZON® Spinal System components cleared in K043151 (S.E. 02/01/2005). 3 3fB VI. Brief Discu… | 2005 |
What descends from it? (606)
See all 6063 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 · 6 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 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K112555 (Medtronic Sofamor Danek USA, Inc., 2011) has gone furthest, with 597 descendants of its own.
- 4 other devices also cite its predicate K081080.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 using bone graft, the TSRH-I Spinal System is indicated as an adjunct to fusion for one or more of the following: (I) 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…
Read the full statement (303 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH-I Spinal System is indicated as an adjunct to fusion for one or more of the following: (I) 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 TSRH9 Spinal System is indicated as an adjunct to fusion for skeletally mature patients using bone graft: (1) having severe spondylolisthiesis (Grades 3 and 4)of thiefifth lumbar-first sacral (L5-SI) vertebral joint: (2) whioare receiving fusions usinig 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-pedlicle 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.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumnbar region, the TSRH-I L-Plate and VANTAGETM screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of. spondylolysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091797: 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/K091797
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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