510(k) · Cleared
ClearedPass Oct Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Mar 21, 2013 as substantially equivalent to K002733 (Depuyacromed, 2000) and 5 other predicates after a 258-day review. Its family tree reaches back 9 generations to 1985. 14 later devices descend from it.
- Decided
- Mar 21, 2013
- Review
- 258 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K853033 (1985). 36 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- This deviceK121979 Pass Oct Spinal SystemMedicrea International · 2013
- Descendant · cites it directly · 13 of its ownK150918 PASS OCT Spinal SystemMedicrea International SA · 2015
- Descendant · 2 generations on · 5 of its ownK173522 Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK191185 Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019
- Descendant · 2 generations on · 4 of its ownK153169 PASS OCT Patient Specific RodsMedicrea International · 2016
- Descendant · 3 generations on · 3 of its ownK210449 Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic · 2021
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- This deviceK121979 Pass Oct Spinal SystemMedicrea International · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K150918PASS OCT Spinal SystemMedicrea International SA · 2015 · cites it directly13descendants
- K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017 · 2 generations on5descendants
- K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019 · 3 generations on4descendants
- K153169PASS OCT Patient Specific RodsMedicrea International · 2016 · 2 generations on4descendants
- K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K121979 | Pass Oct Spinal System | Medicrea International | 2013 | — |
| +1 | K150918 | PASS OCT Spinal System | Medicrea International SA | 2015 | — |
| +2 | K173522 | Solanas® Posterior Stabilization System | Alphatec Spine, Inc. | 2017 | — |
| +3 | K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine | 2019 | — |
| +2 | K153169 | PASS OCT Patient Specific Rods | Medicrea International | 2016 | — |
| +3 | K210449 | Infinity™ OCT System, PASS OCT® Spinal System | Medtronic | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 3 | 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? (6)
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 3…ION Not Applicable CONCLUSIONS DRAWN FROM NON-CLINICAL AND CUINICAL DATA MEDICREAO INTERNATIONAL PASS OCT Spinal system is substantially equivalent to the SUMMIT System (K002733), the Mountaineer OCT Spinal System (K042508), the Vertex Reconstruction System (1(052734), in terms of intended use, materials u… | 2000 |
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 3…-CLINICAL AND CUINICAL DATA MEDICREAO INTERNATIONAL PASS OCT Spinal system is substantially equivalent to the SUMMIT System (K002733), the Mountaineer OCT Spinal System (K042508), the Vertex Reconstruction System (1(052734), in terms of intended use, materials used, design, mechanical safety and performanc… | 2004 |
| * | K062136 | Pass 2 Spinal SystemSummary page 1…____ (OCT) Spinal System K(042508 Mountaineer OCT Spinal System 7/10/04 K(062136 PASS 2 Spinal System 6/10/06 K003780 Vertex Reconstruction System… | 2006 |
| * | K003780 | Vertex Reconstruction SystemSummary page 1…Mountaineer OCT Spinal System 7/10/04 K(062136 PASS 2 Spinal System 6/10/06 K003780 Vertex Reconstruction System 9/28/01 Device Description The PASS OCT Spinal System is a posterior system… | 2001 |
| * | K052734 | Modification to: Vertex Reconstruction SystemSummary page 3…IONAL PASS OCT Spinal system is substantially equivalent to the SUMMIT System (K002733), the Mountaineer OCT Spinal System (K042508), the Vertex Reconstruction System (1(052734), in terms of intended use, materials used, design, mechanical safety and performances. And MEDICREAO INTERNATIONAL PASS OCT Spin… | 2005 |
| * | K041203 | Summit Oct Spinal SystemSummary page 3…terms of materials used and design. The MEDICREAO INTERNATIONAL PASS OCT Spinal System is safe and effective and performs as well as the predicates SUMMIT Spinal System (K041203), the Mountaineer OCT Spinal System (K042508), the Vertex Reconstruction System (K(52734), and the PASS 2 Spinal System (K(062136… | 2004 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150918 | PASS OCT Spinal System | 2015 | 13 |
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.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K150918 (Medicrea International SA, 2015) has gone furthest, with 13 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. 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?
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for: -Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies. - Spondylolisthesis - Spinal Stenosis - Trauma (i.e. Fracture or Dislocation) - Atlanto/axial fracture with instability - Revision of…
Read the full statement (236 words)
When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:
-Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
- Spondylolisthesis
- Spinal Stenosis
- Trauma (i.e. Fracture or Dislocation)
- Atlanto/axial fracture with instability
- Revision of previous cervical spine surgery
- Tumors
Occipital Plates!/ Occipital Bone Screws / Hooks:
The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
The use of the occipital plate requires bilateral fixation to C2 and below.
Note: segmental fixation is recommended for these constructs.
Hooks and rods:
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Polvaxial screws/Connectors:
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
The PASS OCT Spinal System can also be linked to the PASS LP9 Spinal System using the dual diameter rod.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121979: Pass 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/K121979
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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