510(k) · Cleared
ClearedPioneer Posterior Occipito-Cervico-Thoracic (Oct) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 7, 2012 as substantially equivalent to K112757 (Pioneer Surgical Technology, Inc., 2012) and 3 other predicates after a 148-day review. Its family tree reaches back 14 generations to 2001. 17 later devices descend from it.
- Decided
- Nov 7, 2012
- Review
- 148 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K003155 (2001). 104 ancestors in all, the oldest K841189 (1984). 17 later devices descend from it, 5 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 2 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- This deviceK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK171369 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017
- Descendant · 2 generations on · 6 of its ownK200130 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
- Descendant · 3 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK133374 Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
- Descendant · 2 generations on · 2 of its ownK150254 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · Recalled
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 4 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 2 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- This deviceK121725 Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc. · 2012
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2017 · cites it directly8descendants
- K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 2 generations on6descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on3descendants
- K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · cites it directly3descendants
- K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −4 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −2 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −1 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| 0 (this device) | K121725 | Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +1 | K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2017 | — |
| +2 | K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020 | — |
| +3 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +1 | K133374 | Streamline Oct Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014 | — |
| +2 | K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 22 | 0 |
| 2005 | 10 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K112757 | Pioneer Posterior Cervico Thoracic SystemSummary page 1…le screw spinal system Product Codes: KWP, MNH, MN!; Panel Code: 87 Predicate Devices: Pioneer Posterior Cervico-Thoracic System (K 112757) Biomet Spine Nextgen Altius OCT System (K 113593) DePuy Mountaineer OC… | 2012 |
| * | K113593 | Nextgen Altius Oct SystemSummary page 1…!; Panel Code: 87 Predicate Devices: Pioneer Posterior Cervico-Thoracic System (K 112757) Biomet Spine Nextgen Altius OCT System (K 113593) DePuy Mountaineer OCT (K042508) Aesculap Spine: S4 Cervical System (K… | 2012 |
| * | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal SystemSummary page 1…ior Cervico-Thoracic System (K 112757) Biomet Spine Nextgen Altius OCT System (K 113593) DePuy Mountaineer OCT (K042508) Aesculap Spine: S4 Cervical System (K 100 147) Description: The Pioneer Posterior… | 2004 |
| * | K100147 | S4 Cervical Occipital Plate Spinal SystemSummary page 1…Spine Nextgen Altius OCT System (K 113593) DePuy Mountaineer OCT (K042508) Aesculap Spine: S4 Cervical System (K 100 147) Description: The Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System consists of a… | 2010 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171369 | M.U.S.T. MINI Posterior Cervical Screws System | 2017 | 8 |
| K133374 | Streamline Oct Occipito-Cervico-Thoracic System | 2014 | 3 |
| K132504 | Tiger Occipital-Cervical-Thoracic Spinal Fixation System | 2013 | 2 |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | 2020 | 0 |
| K152211 | PCT System | 2015 | 0 |
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 11 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 8 of the 104 ancestors have a recall of any class.
- Of its descendants, K171369 (Medacta International S.A., 2017) has gone furthest, with 8 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture! dislocation, atlanto/axial fracture with instability…
Read the full statement (174 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture! dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery.
The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine.
The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture! dislocation or trauma in the cervical! upper thoracic (CI-T3) spine.
The Pioneer Posterior OCT System can also be linked to FDA cleared pedicle screw systems (e.g., Quantum Spinal Fixation System or Streamline TL Spinal System) using connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121725: Pioneer Posterior Occipito-Cervico-Thoracic (Oct) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121725
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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