510(k) · Cleared
ClearedMountaineer Oct Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Apr 7, 2011 as substantially equivalent to K042508 (Depuy Spine, Inc., 2004) and 1 other predicate after a 59-day review. Its family tree reaches back 10 generations to 1985. 156 later devices descend from it.
- Decided
- Apr 7, 2011
- Review
- 59 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K853033 (1985). 16 ancestors in all. 156 later devices descend from it, 13 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 backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- This deviceK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- Descendant · cites it directly · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · cites it directly · 44 of its ownK113654 CaspianK2m, Inc. · 2012
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 backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- This deviceK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
Showing 5 of 156 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 156 · See all- K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly102descendants
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
- K113654CaspianK2m, Inc. · 2012 · cites it directly44descendants
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 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K080828 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K110353 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2011 | — |
| +1 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| +2 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| +3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| +2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +1 | K113654 | Caspian | K2m, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 15 | 0 |
| 2015 | 13 | 0 |
| 2016 | 6 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 4 | 0 |
| 2020 | 15 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 12 | 0 |
| 2024 | 17 | 0 |
| 2025 | 10 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 1…n orthosis per 21 CFR §888.3050 0. Predicate Device Name Trade names: DePuy MOUNTAINEER OCT Spinal System (K042508, K080828) E. Device Description The MOUNTAINEER OCT Spinal System consists of plates, nuts, bone screws, rods, t… | 2004 |
| * | K080828 | Mountaineer Oct Spinal SystemSummary page 1…s per 21 CFR §888.3050 0. Predicate Device Name Trade names: DePuy MOUNTAINEER OCT Spinal System (K042508, K080828) E. Device Description The MOUNTAINEER OCT Spinal System consists of plates, nuts, bone screws, rods, transverse… | 2008 |
What descends from it? (156)
See all 15613 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113593 | Nextgen Altius Oct System | 2012 | 102 |
| K113654 | Caspian | 2012 | 44 |
| K120656 | Everest Spinal System | 2012 | 43 |
| K171444 | YUKON OCT Spinal System | 2017 | 13 |
| K182182 | YUKON OCT Spinal System | 2018 | 5 |
| K132332 | Mountaineer Oct Spinal System | 2013 | 4 |
| K121877 | Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod… | 2013 | 4 |
| K133374 | Streamline Oct Occipito-Cervico-Thoracic System | 2014 | 3 |
| K132504 | Tiger Occipital-Cervical-Thoracic Spinal Fixation System | 2013 | 2 |
| K182837 | M.U.S.T. Mini Extension | 2019 | 1 |
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 26 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K113593 (Biomet Spine (Aka Ebi, LLC), 2012) has gone furthest, with 102 descendants of its own.
- 20 other devices also cite its predicate K042508.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for: * ODD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * spondylolisthesis * spinal stenosis * fracture/dislocation * atlanto/axial fracture with instability * occipitocervical dislocation *…
Read the full statement (167 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
* ODD (neck pain of discogenic origin with degeneration of the disc as 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
* tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and 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.
The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110353: Mountaineer 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/K110353
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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