510(k) · Cleared
ClearedMountaineer Oct Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 22, 2013 as substantially equivalent to K041203 (Depuy Spine, Inc., 2004) and 3 other predicates after a 27-day review. Its family tree reaches back 11 generations to 1985. 4 later devices descend from it.
- Decided
- Aug 22, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K853033 (1985). 17 ancestors in all. 4 later devices descend from it, 2 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 deviceK132332 Mountaineer Oct Spinal SystemMedos International SARL · 2013
- Descendant · cites it directly · 2 of its ownK150254 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK161498 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016
- Descendant · cites it directly · 0 of its ownK181350 ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK172139 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2017
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 deviceK132332 Mountaineer Oct Spinal SystemMedos International SARL · 2013
Most influential descendants
Showing 4 of 4 · See all- K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · cites it directly2descendants
- K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016 · 2 generations on1descendant
- K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018 · cites it directly0descendants
- K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2017 · 3 generations on0descendants
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) | K132332 | Mountaineer Oct Spinal System | Medos International SARL | 2013 | — |
| +1 | K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015 | 3 |
| +2 | K161498 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2016 | — |
| +1 | K181350 | ASTRA-OCT Spine System | Spinecraft, LLC | 2018 | — |
| +3 | K172139 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2017 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K041203 | Summit Oct Spinal SystemSummary page 1…Pedlicle screw spinal system per 21 CFR §888.3070 D. Predicate Device Name Trade name: MOUNTAINEER® OCT Spinal System (K041203, K042508, K080828, and K110353) P… | 2004 |
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 1…screw spinal system per 21 CFR §888.3070 D. Predicate Device Name Trade name: MOUNTAINEER® OCT Spinal System (K041203, K042508, K080828, and K110353) Page 1 ==… | 2004 |
| * | K080828 | Mountaineer Oct Spinal SystemSummary page 1…inal system per 21 CFR §888.3070 D. Predicate Device Name Trade name: MOUNTAINEER® OCT Spinal System (K041203, K042508, K080828, and K110353) Page 1 === Page 2… | 2008 |
| * | K110353 | Mountaineer Oct Spinal SystemSummary page 1…per 21 CFR §888.3070 D. Predicate Device Name Trade name: MOUNTAINEER® OCT Spinal System (K041203, K042508, K080828, and K110353) Page 1… | 2011 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K150254 (Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.), 2015) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate K041203.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following: DOD (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…
Read the full statement (158 words)
The MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following:
DOD (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 (Tl-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The SONGER® wire/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, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM 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/K132332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132332: 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/K132332
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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