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 Dec 23, 2010 as substantially equivalent to K010720 (Medtronic Sofamor Danek, Inc., 2001) and 2 other predicates after a 69-day review. Its family tree reaches back 5 generations to 2004. 244 later devices descend from it.
- Decided
- Dec 23, 2010
- Review
- 69 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K040583 (2004). 21 ancestors in all, the oldest K982990 (1998). 244 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 2 generations backK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- 1 generation backK093058 TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2009
- This deviceK103049 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 242 of its ownK111942 TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 2 generations on · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · 2 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
- Descendant · 3 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
- Descendant · 4 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
Showing 5 of 244 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 244 · See all- K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly242descendants
- K123138Pass LP Spinal SystemMedicrea International · 2013 · 2 generations on132descendants
- K121630Range Spinal SystemK2m, Inc. · 2012 · 2 generations on127descendants
- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 3 generations on84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 4 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −2 | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −1 | K093058 | TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2009 | — |
| 0 (this device) | K103049 | TSRH Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K111942 | TSRH Spinal Systems | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +2 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +2 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| +3 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
| +4 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
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 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 10 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 14 | 0 |
| 2018 | 17 | 0 |
| 2019 | 9 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 24 | 0 |
| 2023 | 26 | 0 |
| 2024 | 29 | 0 |
| 2025 | 30 | 0 |
| 2026 | 30 | 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 |
|---|---|---|---|
| * | K010720 | TSRH Spinal SystemSummary page 3…annealed. The legally marketed predicates are the TSRH@ Titanium Alloy 5.5mm diameter precut, contoured rods cleared by the Agency in the K(010720 (S.E. 04/11/2001), the TSRHO Titanium Alloy 6.35mm diameter precut, contoured rods cleared by the Age… | 2001 |
| * | K022778 | Modification to TSRH Spinal SystemSummary page 4…substantially equivalent to other commercially available fixation systems including the TSRH@ Spinal System in K4010720 (S.E. 04/11/2001), K022778 (S.E. 09/18S/2002) and K4093058 (S.E. 10/28/2009). V1. Discussion of the Non-Clinical Testing… | 2002 |
| * | K093058 | TSRH Spinal SystemSummary page 3…Subject TSRHO Spinal System CD HORIZON Spinal System TSRI4@ Spinal System (KOiO72,O,(22778) (K093058) Pro-Cut Contoured Rods Material Wrought Cobalt - 28Chromium Wrought Cobalt - 28… | 2009 |
What descends from it? (244)
See all 2442 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K111942 (Medtronic Sofamor Danek USA, Inc., 2011) has gone furthest, with 242 descendants of its own.
- 2 other devices also cite its predicate K010720.
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, the TSRH@ Spinal System is Indicated for one or more of the followng (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 (285 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 followng (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 ThRH® Spinal System is Indicated for skeletally mature patients: (±) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L.5-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 (13 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 b9 patient history and radiographic studies), (2),spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scollosis, 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/lumbar region, the TSRH8 1-Plate and VANTAGEW screws are Intended for the following Indications: spondylolisthesis; trauma (ILe., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosls; and/or failed previous fusion.
For anterior use only the TSRHO Spinal System has the additional indication of: spondylolysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103049: 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/K103049
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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