510(k) · Cleared
ClearedProtex CT Cervicothoracic Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 21, 2005 as substantially equivalent to K003780 (Medtronic Sofamor Danek, Inc., 2001) and 5 other predicates after a 155-day review. Its family tree reaches back 8 generations to 1985. 1 of the 168 devices in its family, counting itself, has a Class I recall. 148 later devices descend from it.
- Decided
- Jul 21, 2005
- Review
- 155 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K853033 (1985). 19 ancestors in all. 148 later devices descend from it, 7 citing it directly. 1 of the 168 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 6 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 5 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 4 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 3 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 2 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 1 generation backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- This deviceK050391 Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2005
- Descendant · cites it directly · 104 of its ownK081906 Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2008
- Descendant · cites it directly · 101 of its ownK090565 Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc. · 2009
- Descendant · cites it directly · 98 of its ownK110963 Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
Showing 5 of 148 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 148 · See all- K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2008 · cites it directly104descendants
- K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc. · 2009 · cites it directly101descendants
- K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc. · 2011 · cites it directly98descendants
- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · cites it directly97descendants
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · cites it directly96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −7 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −6 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −5 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −4 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −3 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −2 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −1 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K050391 | Protex CT Cervicothoracic Spinal System | Globus Medical, Inc. | 2005 | — |
| +1 | K081906 | Protex CT Cervicothoracic Spinal System | Globus Medical, Inc. | 2008 | — |
| +1 | K090565 | Ellipse Occipito-Cerico-Thoracic Spinal System | Globus Medical, Inc. | 2009 | — |
| +1 | K110963 | Ellipse Occipito-Cervico-Thoracic Spinal System | Globus Medical, Inc. | 2011 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 1 |
| 2022 | 9 | 0 |
| 2023 | 13 | 0 |
| 2024 | 24 | 0 |
| 2025 | 17 | 0 |
| 2026 | 19 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K003780 | Vertex Reconstruction SystemSummary page 1…on Orthosis 21 CFR §888.3070 Pedicle Screw Spinal System Product codes KWP and MNI. Panel code is 87. Device classification Class II. PREDICATE DEVICES: Danek Vertex (K003780, K042524) Depuy Summit (K002733, K041203) Howmedica Osteonics (Stryker) Oasys (K032394) Synthes Cervifix/Axon (K023675) DEVICE D… | 2001 |
| * | K042524 | Modification to Vertex Reconstruction SystemSummary page 1…is 21 CFR §888.3070 Pedicle Screw Spinal System Product codes KWP and MNI. Panel code is 87. Device classification Class II. PREDICATE DEVICES: Danek Vertex (K003780, K042524) Depuy Summit (K002733, K041203) Howmedica Osteonics (Stryker) Oasys (K032394) Synthes Cervifix/Axon (K023675) DEVICE DESCRIPTIO… | 2004 |
| * | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…dicle Screw Spinal System Product codes KWP and MNI. Panel code is 87. Device classification Class II. PREDICATE DEVICES: Danek Vertex (K003780, K042524) Depuy Summit (K002733, K041203) Howmedica Osteonics (Stryker) Oasys (K032394) Synthes Cervifix/Axon (K023675) DEVICE DESCRIPTION: The PROTEXTM CT Spi… | 2000 |
| * | K041203 | Summit Oct Spinal SystemSummary page 1…ew Spinal System Product codes KWP and MNI. Panel code is 87. Device classification Class II. PREDICATE DEVICES: Danek Vertex (K003780, K042524) Depuy Summit (K002733, K041203) Howmedica Osteonics (Stryker) Oasys (K032394) Synthes Cervifix/Axon (K023675) DEVICE DESCRIPTION: The PROTEXTM CT Spinal Syste… | 2004 |
| * | K032394 | Stryker Spine Oasys SystemSummary page 1…nel code is 87. Device classification Class II. PREDICATE DEVICES: Danek Vertex (K003780, K042524) Depuy Summit (K002733, K041203) Howmedica Osteonics (Stryker) Oasys (K032394) Synthes Cervifix/Axon (K023675) DEVICE DESCRIPTION: The PROTEXTM CT Spinal System consists of rods, polyaxial screws, hooks, l… | 2004 |
| * | K023675 | Synthes Cervifix/ AxonSummary page 1…ation Class II. PREDICATE DEVICES: Danek Vertex (K003780, K042524) Depuy Summit (K002733, K041203) Howmedica Osteonics (Stryker) Oasys (K032394) Synthes Cervifix/Axon (K023675) DEVICE DESCRIPTION: The PROTEXTM CT Spinal System consists of rods, polyaxial screws, hooks, locking caps, t-connectors, later… | 2002 |
What descends from it? (148)
See all 1487 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081906 | Protex CT Cervicothoracic Spinal System | 2008 | 104 |
| K090565 | Ellipse Occipito-Cerico-Thoracic Spinal System | 2009 | 101 |
| K110963 | Ellipse Occipito-Cervico-Thoracic Spinal System | 2011 | 98 |
| K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | 2013 | 97 |
| K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | 2015 | 96 |
| K101084 | Caspian Spinal System | 2010 | 62 |
| K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | 2021 | 3 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K081906 (Globus Medical, Inc., 2008) has gone furthest, with 104 descendants of its own.
- 20 other devices also cite its predicate K003780.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the PROTEXTM CT Spinal System is indicated for: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of…
Read the full statement (139 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the PROTEXTM CT Spinal System is indicated for: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.
The PROTEXTM CT System can also be linked to titanium rod systems ranging in diameter from 3.7mm to 6.5mm, including the PROTEXTM System, using parallel connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050391: Protex CT Cervicothoracic 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/K050391
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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