510(k) · Cleared
ClearedSummit Occipito-Cervico- Thoracic (Oct) Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 7, 2001 as substantially equivalent to K002733 (Depuyacromed, 2000) and 2 other predicates after a 41-day review. Its family tree reaches back 4 generations to 1985. 2 of the 671 devices in its family, counting itself, have a Class I recall. 660 later devices descend from it.
- Decided
- Nov 7, 2001
- Review
- 41 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K853033 (1985). 10 ancestors in all. 660 later devices descend from it, 8 citing it directly. 2 of the 671 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 3 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 2 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 1 generation backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- This deviceK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- Descendant · cites it directly · 659 of its ownK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- Descendant · cites it directly · 658 of its ownK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- Descendant · cites it directly · 657 of its ownK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- Descendant · 2 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- Descendant · 3 generations on · 424 of its ownK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
Showing 5 of 660 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 660 · See all- K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002 · cites it directly659descendants
- K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003 · cites it directly658descendants
- K041203Summit Oct Spinal SystemDepuy Spine, Inc. · 2004 · cites it directly657descendants
- K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on490descendants
- K063156Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 3 generations on424descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −3 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −2 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| 0 (this device) | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| +1 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| +1 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| +1 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| +2 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| +3 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 13 | 0 |
| 2009 | 10 | 0 |
| 2010 | 12 | 1 |
| 2011 | 15 | 0 |
| 2012 | 28 | 0 |
| 2013 | 30 | 0 |
| 2014 | 31 | 0 |
| 2015 | 38 | 0 |
| 2016 | 29 | 0 |
| 2017 | 37 | 0 |
| 2018 | 38 | 0 |
| 2019 | 32 | 0 |
| 2020 | 38 | 0 |
| 2021 | 33 | 1 |
| 2022 | 38 | 0 |
| 2023 | 66 | 0 |
| 2024 | 57 | 0 |
| 2025 | 50 | 0 |
| 2026 | 49 | 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.
2 devices in this family have 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? (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 |
|---|---|---|---|
| * | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…780 Karen F. Jurczak September 26, 2001 Appliance, Fixation, Spinal interlaminal Orthosis, Spinal Pedicle Fixation Summit OCT Spinal System Summit OCT Spinal System (K002733, K010681) Synthes CerviFix System (K0O01864) When intended to promote fusion of the cervical spine and occipito-cervico-thoracic… | 2000 |
| * | K010681 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…n F. Jurczak September 26, 2001 Appliance, Fixation, Spinal interlaminal Orthosis, Spinal Pedicle Fixation Summit OCT Spinal System Summit OCT Spinal System (K002733, K010681) Synthes CerviFix System (K0O01864) When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction… | 2001 |
| * | K001864 | Synthes Cervifix System | 2000 |
What descends from it? (660)
See all 6608 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | 2002 | 659 |
| K030103 | Summit Oct Spinal System Minipolyaxial Screws | 2003 | 658 |
| K041203 | Summit Oct Spinal System | 2004 | 657 |
| K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | 2004 | 301 |
| K080828 | Mountaineer Oct Spinal System | 2008 | 242 |
| K050979 | S4 Spinal System | 2005 | 67 |
| K062934 | Sierra | 2006 | 21 |
| K181350 | ASTRA-OCT Spine System | 2018 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K022190 (Depuyacromed, 2002) has gone furthest, with 659 descendants of its own.
- 15 other devices also cite its predicate K002733.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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-Cervico-Thoracic (OCT) Spinal System is indicated 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…
Read the full statement (153 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated 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 allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013222: Summit Occipito-Cervico- Thoracic (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/K013222
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026