510(k) · Cleared
ClearedOrthros Posterior Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 8, 2014 as substantially equivalent to K121728 (Corelink, LLC, 2012) and 4 other predicates after a 158-day review. Its family tree reaches back 15 generations to 1985. 1 of the 204 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Apr 8, 2014
- Review
- 158 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K853033 (1985). 201 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly. 1 of the 204 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 2 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 1 generation backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- This deviceK133366 Orthros Posterior Stabilization SystemCamber Spine · 2014
- Descendant · cites it directly · 1 of its ownK180980 ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior…Camber Spine Technologies, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK220038 Camber Spine Navigation SystemCamber Spine Technologies · 2022
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 2 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 1 generation backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- This deviceK133366 Orthros Posterior Stabilization SystemCamber Spine · 2014
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −2 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −1 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| 0 (this device) | K133366 | Orthros Posterior Stabilization System | Camber Spine | 2014 | — |
| +1 | K180980 | ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization… | Camber Spine Technologies, LLC | 2018 | — |
| +2 | 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 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 19 | 0 |
| 2002 | 7 | 0 |
| 2003 | 12 | 0 |
| 2004 | 22 | 0 |
| 2005 | 22 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 0 |
| 2008 | 10 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 1 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K121728 | Tiger Spine SystemSummary page 1…on Panel: Orthopedic Product Code NKB, MNI, MNH, KWQ Reason for 510k New Device Predicate Devices Corelink Tiger Spine System (K121728), Globus Medical Revere Stabilization System (K06l202,tlobus Medical Creo Stabilization… | 2012 |
| * | K061202 | Revere Stabilization System | 2006 |
| * | K124058 | Creo Stabilization SystemSummary page 1…e System (K121728), Globus Medical Revere Stabilization System (K06l202,tlobus Medical Creo Stabilization System (K124058), Medtronic CD Horizaon Legacy 4.5mm System (K(113395) and Synthes Pagea Monoaxial System (K(052151)… | 2013 |
| * | K113395 | Revere 4.5 Stabilization SystemSummary page 1…System (K06l202,tlobus Medical Creo Stabilization System (K124058), Medtronic CD Horizaon Legacy 4.5mm System (K(113395) and Synthes Pagea Monoaxial System (K(052151) K13336… | 2012 |
| * | K052151 | Synthes Pangea Monoaxial SystemSummary page 1…tion System (K124058), Medtronic CD Horizaon Legacy 4.5mm System (K(113395) and Synthes Pagea Monoaxial System (K(052151) K133366 - Page 2 of 4 Device Description… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180980 | ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System | 2018 | 1 |
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 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 201 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180980 (Camber Spine Technologies, LLC, 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K121728.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
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 (TI-SI/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative…
Read the full statement (141 words)
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 (TI-SI/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 (pseudaxthrosis).
In addition, Orthros Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the 1--S I 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 as stated in the FDA summary.
https://510kreport.com/device/K133366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133366: Orthros Posterior Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133366
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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