510(k) · Cleared
ClearedCaspian
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 Jan 12, 2012 as substantially equivalent to K081107 (K2m, Inc., 2008) and 2 other predicates after a 31-day review. Its family tree reaches back 11 generations to 1985. 44 later devices descend from it.
- Decided
- Jan 12, 2012
- Review
- 31 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K853033 (1985). 28 ancestors in all. 44 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- 1 generation backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- This deviceK113654 CaspianK2m, Inc. · 2012
- Descendant · cites it directly · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
- Descendant · 2 generations on · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- Descendant · 2 generations on · 31 of its ownK140529 Everest Spinal SystemK2m, LLC · 2014
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- 1 generation backK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- This deviceK113654 CaspianK2m, Inc. · 2012
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
- K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
- K132361Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on34descendants
- K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · 2 generations on33descendants
- K140529Everest Spinal SystemK2m, LLC · 2014 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K080828 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2008 | — |
| −1 | K110353 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2011 | — |
| 0 (this device) | K113654 | Caspian | K2m, Inc. | 2012 | — |
| +1 | K120656 | Everest Spinal System | K2m, Inc. | 2012 | — |
| +2 | K132757 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +2 | K132361 | Everest Spinal System | K2m, Inc. | 2013 | — |
| +2 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| +2 | K140529 | Everest Spinal System | K2m, LLC | 2014 | — |
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 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (3)
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 |
|---|---|---|---|
| * | K081107 | Caspian Spinal System, Screws, Rods, Hooks, Rod ConnectorsSummary page 1…Regulatory Class: Class If 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Caspian Spinal System (K081 107, K101084) * De~uy Mountaineer (KI 10353) 4. Description of the device: The Caspian Spinal System is a top-loa… | 2008 |
| * | K101084 | Caspian Spinal SystemSummary page 1…ory Class: Class If 3. Predicate or legally marketed devices which are substantially equivalent: " K2M Caspian Spinal System (K081 107, K101084) * De~uy Mountaineer (KI 10353) 4. Description of the device: The Caspian Spinal System is a top-loading, mul… | 2010 |
| * | K110353 | Mountaineer Oct Spinal System | 2011 |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120656 | Everest Spinal System | 2012 | 43 |
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 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K120656 (K2m, Inc., 2012) has gone furthest, with 43 descendants of its own.
- 10 other devices also cite its predicate K081107.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/miiniMesalminiDenali Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autografi 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…
Read the full statement (149 words)
The Caspian OCT/miiniMesalminiDenali Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autografi 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-TJ3 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/miniMesa/miniDenali Spinal System can also be linked to the Range Spinal System using the 3.5mm1/5.Smm rod connectors or transitional rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113654: Caspian.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113654
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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