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 May 23, 2011 as substantially equivalent to K896603 (Danek Medical, Inc., 1990) and 2 other predicates after a 74-day review. Its family tree reaches back 2 generations to 2001. 36 later devices descend from it.
- Decided
- May 23, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K014076 (2001). 4 ancestors in all, the oldest K896603 (1990). 36 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK014076 Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
- 1 generation backK021106 Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2002
- This deviceK110676 TSRH Spinal SystemMedtronic Sofamor Danek · 2011
- Descendant · cites it directly · 35 of its ownK120899 Range Spinal System, Unit RodK2m, Inc. · 2012
- Descendant · 2 generations on · 34 of its ownK131030 Range Spinal SystemK2m, Inc. · 2013
- Descendant · 3 generations on · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 4 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- Descendant · 5 generations on · 16 of its ownK143334 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K120899Range Spinal System, Unit RodK2m, Inc. · 2012 · cites it directly35descendants
- K131030Range Spinal SystemK2m, Inc. · 2013 · 2 generations on34descendants
- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · 3 generations on33descendants
- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 4 generations on30descendants
- K143334Range/Denali/Mesa Spinal SystemK2m, Inc. · 2015 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014076 | Modification to TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K021106 | Modification to TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| 0 (this device) | K110676 | TSRH Spinal System | Medtronic Sofamor Danek | 2011 | — |
| +1 | K120899 | Range Spinal System, Unit Rod | K2m, Inc. | 2012 | — |
| +2 | K131030 | Range Spinal System | K2m, Inc. | 2013 | — |
| +3 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +4 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| +5 | K143334 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K896603 | HSC Unit RodSummary page 3…ject Unit Rods and S-Rods are substantially equivalent to TSRH® Spinal System components manufactured by Metronic Sofamor Danek and cleared by the FDA in K896603 (S.E. 01/30/1990), K982990 (S.E. 10/21/1998) and K021 106 (S.E. 05/03/2002). VII. Summarn of the Technological Char… | 1990 |
| * | K982990 | TSRH Spinal SystemSummary page 3…re substantially equivalent to TSRH® Spinal System components manufactured by Metronic Sofamor Danek and cleared by the FDA in K896603 (S.E. 01/30/1990), K982990 (S.E. 10/21/1998) and K021 106 (S.E. 05/03/2002). VII. Summarn of the Technological Characteristics: The pu… | 1998 |
| * | K021106 | Modification to TSRH Spinal SystemSummary page 3…TSRH® Spinal System components manufactured by Metronic Sofamor Danek and cleared by the FDA in K896603 (S.E. 01/30/1990), K982990 (S.E. 10/21/1998) and K021 106 (S.E. 05/03/2002). VII. Summarn of the Technological Characteristics: The purpose of this Special 5 10(k) is to add… | 2002 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120899 | Range Spinal System, Unit Rod | 2012 | 35 |
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 10 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120899 (K2m, Inc., 2012) has gone furthest, with 35 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. 2011, 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® Spinal System is indicated as an adjunct to fusion 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 spondylolis thesis with objective evidence of neurologic…
Read the full statement (306 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated as an adjunct to fusion 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 spondylolis thesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudartlirosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (U5-Si) 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 confinmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, k}'phosis, and/or lordosis), (5) spinal stenosis, (6) pseudaribrosis, (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/lumbar region, the TSRH® 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; pseudoarthrosis; 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/K110676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110676: 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/K110676
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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