510(k) · Cleared
ClearedSpectrum Spine Spinous Process Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Spine IP Holdings, LLC · PEK Spinous Process Plate
Cleared on Nov 12, 2013 as substantially equivalent to K071877 (Lanx, LLC, 2007) and 1 other predicate after a 306-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Nov 12, 2013
- Review
- 306 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032037 (2003). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK130066 Spectrum Spine Spinous Process DeviceSpectrum Spine IP Holdings, LLC · 2013
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) | K130066 | Spectrum Spine Spinous Process Device | Spectrum Spine IP Holdings, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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 PEK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PEK device
- #1 K253250 Minuteman® G6 MIS Fusion Platescore 15.2 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K071877 | Lanx Spinal Fixation SystemSummary page 1…rovide supplemental stabilization of the spinous process to support fusion. Predicate Device The predicate devices are the Lanx Aspen Spinous Process Fusion Plate (K(071877) and the X-spine Axle device (K(112592). Intended Use / Indications for Use The Spectrum SPINOUS PROCESS DEVICE is a posterio… | 2007 |
| * | K112592 | Axle Peek Interspinous Fusion SystemSummary page 1…spinous process to support fusion. Predicate Device The predicate devices are the Lanx Aspen Spinous Process Fusion Plate (K(071877) and the X-spine Axle device (K(112592). Intended Use / Indications for Use The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation de… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 17 other devices also cite its predicate K071877.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PEK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEK
60in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PEK
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEK
3in 2025
MAUDE reports naming product code PEK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 10 | 118 | 0 | 0 |
| 2014 | 8 | 120 | 0 | 2 |
| 2015 | 6 | 166 | 0 | 3 |
| 2016 | 4 | 176 | 0 | 0 |
| 2017 | 3 | 94 | 0 | 0 |
| 2018 | 4 | 69 | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 2 | — | 1 | 17 |
| 2022 | 3 | 135 | 0 | 11 |
| 2023 | 4 | 60 | 0 | 8 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (Ti-Si inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130066: Spectrum Spine Spinous Process Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130066
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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