510(k) · Cleared
ClearedModification to TSRH Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 3, 2002 as substantially equivalent to K014076 (Medtronic Sofamor Danek, Inc., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 37 later devices descend from it.
- Decided
- May 3, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K014076 (2001). 37 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK014076 Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
- This deviceK021106 Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · cites it directly · 36 of its ownK110676 TSRH Spinal SystemMedtronic Sofamor Danek · 2011
- Descendant · 2 generations on · 35 of its ownK120899 Range Spinal System, Unit RodK2m, Inc. · 2012
- Descendant · 3 generations on · 34 of its ownK131030 Range Spinal SystemK2m, Inc. · 2013
- Descendant · 4 generations on · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 5 generations on · 30 of its ownK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K110676TSRH Spinal SystemMedtronic Sofamor Danek · 2011 · cites it directly36descendants
- K120899Range Spinal System, Unit RodK2m, Inc. · 2012 · 2 generations on35descendants
- K131030Range Spinal SystemK2m, Inc. · 2013 · 3 generations on34descendants
- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · 4 generations on33descendants
- K141873Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014 · 5 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K014076 | Modification to TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| 0 (this device) | K021106 | Modification to TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +1 | K110676 | TSRH Spinal System | Medtronic Sofamor Danek | 2011 | — |
| +2 | K120899 | Range Spinal System, Unit Rod | K2m, Inc. | 2012 | — |
| +3 | K131030 | Range Spinal System | K2m, Inc. | 2013 | — |
| +4 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +5 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 MNI? 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? (1)
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 |
|---|---|---|---|
| * | K014076 | Modification to TSRH Spinal SystemSummary page 1…m III. Description 7 The purpose of this Special 510(k) is to add the use of rods which are physically identical to the rods already cleared in the TSRH® Spinal System (K014076). The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting com… | 2001 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110676 | TSRH Spinal System | 2011 | 36 |
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?
- Its one ancestor has no recall.
- Of its descendants, K110676 (Medtronic Sofamor Danek, 2011) has gone furthest, with 36 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system…
Read the full statement (271 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) 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) vertebral joint; (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 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 (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateral thoracic/lumbar 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 (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021106: Modification to 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/K021106
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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