510(k) · Decided
DecidedTSRH Spinal Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 30, 2011 as substantially equivalent to K093058 (Medtronic Sofamor Danek, Inc., 2009) and 2 other predicates after a 53-day review. Its family tree reaches back 6 generations to 2004. 242 later devices descend from it.
- Decided
- Aug 30, 2011
- Review
- 53 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K040583 (2004). 42 ancestors in all, the oldest K781443 (1978). 242 later devices descend from it, 4 citing it directly.
- 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 backK093058 TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2009
- 1 generation backK103049 TSRH Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK111942 TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · cites it directly · 132 of its ownK123138 Pass LP Spinal SystemMedicrea International · 2013
- Descendant · cites it directly · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 84 of its ownK142798 PASS LP Spinal SystemMedicrea International SA · 2015
- Descendant · 3 generations on · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- Descendant · 2 generations on · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
Showing 5 of 242 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 242 · See all- K123138Pass LP Spinal SystemMedicrea International · 2013 · cites it directly132descendants
- K121630Range Spinal SystemK2m, Inc. · 2012 · cites it directly127descendants
- K142798PASS LP Spinal SystemMedicrea International SA · 2015 · 2 generations on84descendants
- K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · 3 generations on83descendants
- K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · 2 generations on81descendants
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 | K093058 | TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2009 | — |
| −1 | K103049 | TSRH Spinal System | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K111942 | TSRH Spinal Systems | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | K123138 | Pass LP Spinal System | Medicrea International | 2013 | — |
| +1 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| +2 | K142798 | PASS LP Spinal System | Medicrea International SA | 2015 | — |
| +3 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| +2 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 10 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 10 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 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 |
|---|---|---|---|
| * | K093058 | TSRH Spinal SystemSummary page 3…nealed. The legally marketed predicate is the CD HORIZON® Chromaloy 5.5mm dlameter x 500mm long rod cleared to be used with the TSRH® Spinal System by the Agency in the K093058 (S.E. 10/28/2009) and the TSRH® Chromaloy+ Precut Contoured 5.5mm Diameter Rods In lengths from 30mm - 120mm cleared in K103049 (… | 2009 |
| * | K103049 | TSRH Spinal SystemSummary page 3…TSRH® Spinal System by the Agency in the K093058 (S.E. 10/28/2009) and the TSRH® Chromaloy+ Precut Contoured 5.5mm Diameter Rods In lengths from 30mm - 120mm cleared in K103049 (S.E. 12/23/2010). Vg 3065 vil. Vi, ina4 The table below lists the differences between the predicate devices… | 2010 |
| * | K110070 | TSRH Spinal SystemSummary page 4…substantially equivalent to other commerclally avallable fixatlon systems Including the TSRH® Spinal System In KO93058 (S.E. 10/28/2009), K103049 (S.E. 12/23/2010), and K110070 (S.E. 6/8/2011). Discussion of the Non-Clinical Testing and Fatigue Properties of Interconnection Mechanisms and Subassemblies… | 2011 |
What descends from it? (242)
See all 2424 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 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 4 of the 42 ancestors have a recall of any class.
- Of its descendants, K123138 (Medicrea International, 2013) has gone furthest, with 132 descendants of its own.
- 3 other devices also cite its predicate K093058.
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 allograft and/or. autograft, 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 spondylolisthesis with objective evidence…
Read the full statement (360 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or. autograft, 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 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 TSRH® Spinal System is indicated as an adjunct to fusion for skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) 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, nen-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) spondylolisthesis, (3) fracture, (4) spinal defermities (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/lumbar region, the TSRH® L-Plate and VANTAGE™ 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; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH® Pediatric Spinal System Is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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/K111942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111942: TSRH Spinal Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111942
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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