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 USA, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 9, 2002 after an 88-day review. The FDA summary names its predicate without a number. 127 later devices descend from it.
- Decided
- Jul 9, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
127 later devices descend from it, 5 citing it directly.
- This deviceK021170 TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2002
- Descendant · cites it directly · 86 of its ownK100737 Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010
- Descendant · 2 generations on · 85 of its ownK103292 Trio Trauma Spinal SystemStryker Corporation · 2011
- Descendant · 2 generations on · 84 of its ownK133188 Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio &…Stryker Spine · 2013
- Descendant · 3 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · cites it directly · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 127 · See all- K100737Modification to: Trio+Spinal Fixation SystemStryker Spine · 2010 · cites it directly86descendants
- K103292Trio Trauma Spinal SystemStryker Corporation · 2011 · 2 generations on85descendants
- K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine · 2013 · 2 generations on84descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 3 generations on83descendants
- K131250Tiger Spine SystemCorelink, LLC · 2013 · cites it directly40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021170 | TSRH Spinal System | Medtronic Sofamor Danek USA, Inc. | 2002 | — |
| +1 | K100737 | Modification to: Trio+Spinal Fixation System | Stryker Spine | 2010 | — |
| +2 | K103292 | Trio Trauma Spinal System | Stryker Corporation | 2011 | — |
| +2 | K133188 | Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal… | Stryker Spine | 2013 | — |
| +3 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +1 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 21 | 0 |
| 2024 | 17 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | CDB Spinal System 4.0mm screws Named without a submission number | |
| * | — | TSRH Spinal System Named without a submission number |
What descends from it? (127)
See all 1275 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?
- Of its descendants, K100737 (Stryker Spine, 2010) has gone furthest, with 86 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
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@ Spina1 System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc…
Read the full statement (346 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH@ Spina1 System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: (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) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) 'scoliosis, ( 6 ) kyphosis, (7) spinal tumor, and (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: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebraljoint; (b) who are receiving fusions using autogenous bone graft only; (c) 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 defmed by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateraVanterior 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) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (Le., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (Tl-LS) and into anterior vertebral bodies of the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021170: 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/K021170
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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