510(k) · Cleared
ClearedSumit Oct Spinal System and Mountaineer 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 Oct 7, 2004 as substantially equivalent to K002733 (Depuyacromed, 2000) and 6 other predicates after a 22-day review. Its family tree reaches back 8 generations to 1985. 1 of the 316 devices in its family, counting itself, has a Class I recall. 301 later devices descend from it.
- Decided
- Oct 7, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K853033 (1985). 14 ancestors in all. 301 later devices descend from it, 21 citing it directly. 1 of the 316 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 deviceK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- Descendant · cites it directly · 242 of its ownK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 184 of its ownK103100 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2010
- Descendant · cites it directly · 156 of its ownK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
- Descendant · cites it directly · 129 of its ownK073654 Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008
- Descendant · 2 generations on · 124 of its ownK080394 Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008
Showing 5 of 301 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 301 · See all- K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008 · cites it directly242descendants
- K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2010 · 2 generations on184descendants
- K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011 · cites it directly156descendants
- K073654Blackstone Ascent Poct System Parallel Rod ConnectorBlackstone Medical, Inc. · 2008 · cites it directly129descendants
- K080394Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemBlackstone Medical, Inc. · 2008 · 2 generations on124descendants
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) | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| +1 | K080828 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2008 | — |
| +2 | K103100 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2010 | — |
| +1 | K110353 | Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2011 | — |
| +1 | K073654 | Blackstone Ascent Poct System Parallel Rod Connector | Blackstone Medical, Inc. | 2008 | — |
| +2 | K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) System | Blackstone Medical, Inc. | 2008 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 11 | 0 |
| 2013 | 11 | 0 |
| 2014 | 17 | 0 |
| 2015 | 20 | 0 |
| 2016 | 14 | 0 |
| 2017 | 17 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 17 | 1 |
| 2022 | 17 | 0 |
| 2023 | 26 | 0 |
| 2024 | 30 | 0 |
| 2025 | 22 | 0 |
| 2026 | 26 | 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? (7)
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 |
|---|---|---|---|
| * | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…ation PROPRIETARY NAME: Summit OCT Spinal System Mountaineer OCT Spinal System PREDICATE DEVICES: Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103, and K041203) SYNTHES Spine CerviFix S… | 2000 |
| * | K010681 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…OPRIETARY NAME: Summit OCT Spinal System Mountaineer OCT Spinal System PREDICATE DEVICES: Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103, and K041203) SYNTHES Spine CerviFix System (K9… | 2001 |
| * | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemSummary page 1…Spinal System Mountaineer OCT Spinal System PREDICATE DEVICES: Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103, and K041203) SYNTHES Spine CerviFix System (K984377) DEVICE DESCRIPTION: A… | 2001 |
| * | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…stem Mountaineer OCT Spinal System PREDICATE DEVICES: Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103, and K041203) SYNTHES Spine CerviFix System (K984377) DEVICE DESCRIPTION: Addition o… | 2002 |
| * | K030103 | Summit Oct Spinal System Minipolyaxial ScrewsSummary page 1…Mountaineer OCT Spinal System PREDICATE DEVICES: Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103, and K041203) SYNTHES Spine CerviFix System (K984377) DEVICE DESCRIPTION: Addition of compone… | 2003 |
| * | K041203 | Summit Oct Spinal SystemSummary page 1…Mountaineer OCT Spinal System PREDICATE DEVICES: Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103, and K041203) SYNTHES Spine CerviFix System (K984377) DEVICE DESCRIPTION: Addition of components to the Su… | 2004 |
| * | K984377 | Synthes Spine Cervifix SystemSummary page 1…Summit OCT Spinal System (K002733, K010681, K013222, K022190, K030103, and K041203) SYNTHES Spine CerviFix System (K984377) DEVICE DESCRIPTION: Addition of components to the Summit OCT Spinal System and Mountaineer OC… | 1999 |
What descends from it? (301)
See all 30121 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080828 | Mountaineer Oct Spinal System | 2008 | 242 |
| K110353 | Mountaineer Oct Spinal System | 2011 | 156 |
| K073654 | Blackstone Ascent Poct System Parallel Rod Connector | 2008 | 129 |
| K113593 | Nextgen Altius Oct System | 2012 | 102 |
| K103232 | Caspian Spinal System | 2011 | 46 |
| K062934 | Sierra | 2006 | 21 |
| K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | 2012 | 17 |
| K121979 | Pass Oct Spinal System | 2013 | 14 |
| K171444 | YUKON OCT Spinal System | 2017 | 13 |
| K073420 | Blackstone Ascent Multiaxial Screws | 2008 | 9 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K080828 (Depuy Spine, Inc., 2008) has gone furthest, with 242 descendants of its own.
- 15 other devices also cite its predicate K002733.
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 Summit Occipito-Cervical-Thoracic (OCT) Spinal System and the Mountaineer OCT Spinal System is intended for: • ddd (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 •…
Read the full statement (181 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3). the Summit Occipito-Cervical-Thoracic (OCT) Spinal System and the Mountaineer OCT Spinal System is intended for:
• ddd (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 minipolyaxial 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 Summit OCT Spinal System and Mountaineer OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal System and the Mountaineer OCT Spinal System can also be linked to the ISOLA, TiMX, MONARCH, MOSS MIAMI, 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/K042508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042508: Sumit Oct Spinal System and 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/K042508
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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