510(k) · Cleared
ClearedCaspian Oct Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 1, 2014 as substantially equivalent to K101084 (K2m, Inc., 2010) and 1 other predicate after a 249-day review. Its family tree reaches back 10 generations to 1985. 18 later devices descend from it.
- Decided
- Jul 1, 2014
- Review
- 249 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K853033 (1985). 29 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK050391 Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2005
- 1 generation backK101084 Caspian Spinal SystemK2m, Inc. · 2010
- This deviceK133288 Caspian Oct Spinal SystemK2m, Inc. · 2014
- Descendant · cites it directly · 17 of its ownK153370 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016
- Descendant · 2 generations on · 13 of its ownK171444 YUKON OCT Spinal SystemK2m, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK182182 YUKON OCT Spinal SystemK2m · 2018
- Descendant · 2 generations on · 5 of its ownK181603 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System…K2m, Inc. · 2018
- Descendant · 3 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK050391 Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2005
- 1 generation backK101084 Caspian Spinal SystemK2m, Inc. · 2010
- This deviceK133288 Caspian Oct Spinal SystemK2m, Inc. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated · 2016 · cites it directly17descendants
- K171444YUKON OCT Spinal SystemK2m, Inc. · 2017 · 2 generations on13descendants
- K182182YUKON OCT Spinal SystemK2m · 2018 · 2 generations on5descendants
- K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc. · 2018 · 2 generations on5descendants
- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K050391 | Protex CT Cervicothoracic Spinal System | Globus Medical, Inc. | 2005 | — |
| −1 | K101084 | Caspian Spinal System | K2m, Inc. | 2010 | — |
| 0 (this device) | K133288 | Caspian Oct Spinal System | K2m, Inc. | 2014 | — |
| +1 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m, Incorporated | 2016 | — |
| +2 | K171444 | YUKON OCT Spinal System | K2m, Inc. | 2017 | 3 |
| +2 | K182182 | YUKON OCT Spinal System | K2m | 2018 | — |
| +2 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT… | K2m, Inc. | 2018 | — |
| +3 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 KWP? 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? (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 |
|---|---|---|---|
| * | K101084 | Caspian Spinal SystemSummary page 1…KWP Regulatory Class: Class 11 3. Predicate or legally marketed devices which are substantially equivalent " K2M Caspian OCT Spinal System (K 101084) " Medtronic Vertex (K052402) 4. Description of the device: The Caspian OCT Spinal System is a top-loading, multip… | 2010 |
| * | K052402 | Vertex Reconstruction SystemSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent " K2M Caspian OCT Spinal System (K 101084) " Medtronic Vertex (K052402) 4. Description of the device: The Caspian OCT Spinal System is a top-loading, multiple component, posterior (occipita… | 2005 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | 2016 | 17 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 29 ancestors has a recall of any class.
- Of its descendants, K153370 (K2m, Incorporated, 2016) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K101084.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The CASPIAN OCT/MESA Mini/DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervical-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: - DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); - Spondylolisthesis; - Spinal stenosis; - Fracture/dislocation; -…
Read the full statement (160 words)
The CASPIAN OCT/MESA Mini/DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervical-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies);
- Spondylolisthesis;
- Spinal stenosis;
- Fracture/dislocation;
- Revision of previous cervical spine surgery;
- Tumors;
- Atlantoaxial fracture with instability;
- Occipitocervical dislocation
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The CASPIAN OCT/MESA Mini/Denali Mini System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133288: Caspian Oct 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/K133288
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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