510(k) · Cleared
ClearedORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 27, 2018 as substantially equivalent to K133366 (Camber Spine, 2014) and 1 other predicate after a 197-day review. Its family tree reaches back 17 generations to 2004. 1 of the 316 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 27, 2018
- Review
- 197 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K040583 (2004). 314 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 316 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 2 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 1 generation backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- This deviceK180980 ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior…Camber Spine Technologies, LLC · 2018
- Descendant · cites it directly · 0 of its ownK220038 Camber Spine Navigation SystemCamber Spine Technologies · 2022
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121630 Range Spinal SystemK2m, Inc. · 2012
- 4 generations backK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- 3 generations backK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- 2 generations backK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- 1 generation backK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
- This deviceK180980 ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior…Camber Spine Technologies, LLC · 2018
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K220038Camber Spine Navigation SystemCamber Spine Technologies · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| −4 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| −3 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| −2 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| −1 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
| 0 (this device) | K180980 | ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization… | Camber Spine Technologies, LLC | 2018 | — |
| +1 | K220038 | Camber Spine Navigation System | Camber Spine Technologies | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 16 | 0 |
| 1999 | 11 | 0 |
| 2000 | 20 | 0 |
| 2001 | 26 | 0 |
| 2002 | 20 | 0 |
| 2003 | 20 | 0 |
| 2004 | 26 | 0 |
| 2005 | 21 | 0 |
| 2006 | 17 | 0 |
| 2007 | 13 | 0 |
| 2008 | 19 | 0 |
| 2009 | 11 | 0 |
| 2010 | 13 | 1 |
| 2011 | 11 | 0 |
| 2012 | 8 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K133366 | Orthros Posterior Stabilization SystemSummary page 6…n their labelling. The new intended use and the system components for MIS system including the “long towers” was introduced as part of note to file for the existing 510k K133366, but a recent review of the regulatory strategy by an outside regulatory council resulted in a decision to file a 510k for the ad… | 2014 |
| * | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Summary page 6…Technologies ORTHROS™ Posterior Stabilization System (K133366), and the additional predicate Orthofix Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K171082). Predicate Devices Primary Predicate: Camber Spine Technologies ORTHROS™ Posterior Stabilization System (K133366)… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220038 | Camber Spine Navigation System | 2022 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 34 of the 314 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220038 (Camber Spine Technologies, 2022) has gone furthest, with 0 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. 2018, 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?
The ORTHROS™ MIS Posterior Stabilization System, when used in a posterior percutaneous approach is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc…
Read the full statement (295 words)
The ORTHROS™ MIS Posterior Stabilization System, when used in a posterior percutaneous approach is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, ORTHROS™ MIS Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L-3- sacrum/ilium.
The ORTHROS™ Posterior Stabilization System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the ORTHROS™ Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
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/K180980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180980: ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180980
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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