510(k) · Cleared
ClearedPrimal OK Interspinous Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 17, 2010 as substantially equivalent to K043053 (Medtronic Sofamor Danek, 2005) and 1 other predicate after a 186-day review. Its family tree reaches back 3 generations to 2003. 37 later devices descend from it.
- Decided
- Aug 17, 2010
- Review
- 186 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032037 (2003). 5 ancestors in all. 37 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 2 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 1 generation backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- This deviceK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
- Descendant · cites it directly · 30 of its ownK131238 Affix Spinous Process Plate SystemNuvasive, Inc. · 2013
- Descendant · 2 generations on · 18 of its ownK133052 Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013
- Descendant · cites it directly · 18 of its ownK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- Descendant · 3 generations on · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K131238Affix Spinous Process Plate SystemNuvasive, Inc. · 2013 · cites it directly30descendants
- K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013 · 2 generations on18descendants
- K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012 · cites it directly18descendants
- K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013 · 2 generations on12descendants
- K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −2 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −1 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| 0 (this device) | K100354 | Primal OK Interspinous Fusion System | Osteomed LP | 2010 | — |
| +1 | K131238 | Affix Spinous Process Plate System | Nuvasive, Inc. | 2013 | — |
| +2 | K133052 | Affix (R) Next Gen Spinous Process Plate System | Nuvasive, Inc. | 2013 | — |
| +1 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| +2 | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| +3 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K043053 | Modification to CD Horizon Spinal SystemSummary page 1…are manufactured from titanium alloy (Ti-6Ai-4V) as described by ASTM F136. Predicate Devices: CD Horizon® Spire Plate (Medtronic, K043053) Spinous Process Fusion [aka Aspen] Plate (Larnx, Inc., K071 877)… | 2005 |
| * | K071877 | Lanx Spinal Fixation SystemSummary page 1…icate Devices: CD Horizon® Spire Plate (Medtronic, K043053) Spinous Process Fusion [aka Aspen] Plate (Larnx, Inc., K071 877) Page 75 Technological… | 2007 |
What descends from it? (37)
See all 378 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131238 | Affix Spinous Process Plate System | 2013 | 30 |
| K122509 | Vertiflex Spinous Process Fixation Plate | 2012 | 18 |
| K133363 | Interbridge Interspinous Posterior Fixation System | 2014 | 5 |
| K142378 | Interspinous Plate System | 2014 | 3 |
| K121316 | Lanx Spinal Fization System | 2012 | 3 |
| K231807 | primaLOK™ SP Interspinous Fusion System | 2023 | 0 |
| K160465 | Spinal Elements' Spinous Process Plate System | 2016 | 0 |
| K142217 | Reliance Interspinous Plate 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 7 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131238 (Nuvasive, Inc., 2013) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K043053.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Primal-OK TM sp Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (Ti-Si). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOK Tmsp Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100354: Primal OK Interspinous Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100354
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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