510(k) · Cleared
ClearedSP-Fix Spinous Process Fixation Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · PEK Spinous Process Plate
Cleared on Nov 22, 2013 as substantially equivalent to K102195 (Globus Medical, Inc., 2011) and 1 other predicate after a 130-day review. Its family tree reaches back 4 generations to 2003. 6 later devices descend from it.
- Decided
- Nov 22, 2013
- Review
- 130 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K032037 (2003). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 3 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 1 generation backK102195 SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2011
- This deviceK132191 SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2018 · cites it directly5descendants
- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · cites it directly4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 2 generations on2descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 3 generations on0descendants
- K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −3 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −1 | K102195 | SP-Fix Spinous Process Fixation Plate | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K132191 | SP-Fix Spinous Process Fixation Plate | Globus Medical, Inc. | 2013 | — |
| +1 | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018 | — |
| +1 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +2 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +3 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +2 | K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K102195 | SP-Fix Spinous Process Fixation PlateSummary page 1…t Code: PEK Regulatory Class: Class 11,Panel Code 87. Predicate(s): SP-Fix® Spinous Process Fixation Plate (K1 02195) Medtronic SPIRE® (K032037) Purpose: The purpose of this s… | 2011 |
| * | K032037 | CD Horizon (Addition of Spinous Process Plate)Summary page 1…: Class 11,Panel Code 87. Predicate(s): SP-Fix® Spinous Process Fixation Plate (K1 02195) Medtronic SPIRE® (K032037) Purpose: The purpose of this submission is to request clearance for additional SP-Fix®… | 2003 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K180156 (Globus Medical, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K102195.
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 SP-Fix® Spinous Process Fixation Plate is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (Ti-Si). It is intended for plate fixation/attachment to the spinous processes 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 SP-Fix® Spinous Process Fixation Plate is intended for use with bone graft material and is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132191: SP-Fix Spinous Process Fixation Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132191
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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