510(k) · Cleared
ClearedStatera-C™ Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K&J Consulting Corp. · NKG Posterior Cervical Screw System
Cleared on Nov 27, 2023 as substantially equivalent to K150552 (Globus Medical, Inc., 2015) after a 59-day review. Its family tree reaches back 16 generations to 1985.
- Decided
- Nov 27, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K853033 (1985). 202 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 2 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 1 generation backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- This deviceK233332 Statera-C™ Spinal SystemK&J Consulting Corp. · 2023
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 2 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 1 generation backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- This deviceK233332 Statera-C™ Spinal SystemK&J Consulting Corp. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −3 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −2 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| −1 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| 0 (this device) | K233332 | Statera-C™ Spinal System | K&J Consulting Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 9 | 0 |
| 2003 | 11 | 0 |
| 2004 | 27 | 0 |
| 2005 | 22 | 0 |
| 2006 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 14 | 0 |
| 2009 | 12 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2015 | 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 NKG? 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSSummary page 5…uivalent to the legally marketed predicate devices. Predicate Device: Primary predicate: Globus Medical – ELLIPSE® and PROTEX® CT Spinal Systems (K150552) Reference Device: K&J Consulting – Fortis And Hana Anterior Cervical Plate System, Rex Anterior Cervical P… | 2015 |
| † | K231460 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 202 ancestors have a recall of any class.
- 4 other devices also cite its predicate K150552.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The Statera-C™ Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including…
Read the full statement (163 words)
The Statera-C™ Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. It is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Statera-C™ Spinal System may be connected to the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System using corresponding connectors and/or transition rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233332: Statera-C™ 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/K233332
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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