510(k) · Cleared
ClearedIntegra Interspinous Process System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · PEK Spinous Process Plate
Cleared on Sep 4, 2013 as substantially equivalent to K100407 (Life Spine, 2010) and 5 other predicates after a 429-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it.
- Decided
- Sep 4, 2013
- Review
- 429 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K033826 (2004). 10 ancestors in all, the oldest K032037 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 3 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- 2 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
- 1 generation backK090252 Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009
- This deviceK121924 Integra Interspinous Process SystemSeaspine, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK173334 SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −3 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| −2 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| −1 | K090252 | Modification to: Lanx Spinal Fixation System | Lanx, Inc. | 2009 | — |
| 0 (this device) | K121924 | Integra Interspinous Process System | Seaspine, Inc. | 2013 | — |
| +1 | K173334 | SeaSpine Spinous Process System | SeaSpine Orthopedics Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K100407 | Life Spine Interspinous Fixation SystemSummary page 1…lable predicate devices in design, materials, indications and performance: Life Spine interspinous Fixation System K100407 NuVasiveO Spinous Process Plate System K073278… | 2010 |
| * | K073278 | Spinous Process Plate SystemSummary page 1…ndications and performance: Life Spine interspinous Fixation System K100407 NuVasiveO Spinous Process Plate System K073278 3 === Page 2 =… | 2008 |
| * | K090252 | Modification to: Lanx Spinal Fixation SystemSummary page 2…510(k) Summary Page 2 of 2 Lonx Spinous Process Fusion Plate (SPFP) K090252; K083581; K043484 Medtronic CD Horizon Spinous Process P/ate K032037 Technological The t… | 2009 |
| * | K083581 | Lanx Spinal Fixation SystemSummary page 2…510(k) Summary Page 2 of 2 Lonx Spinous Process Fusion Plate (SPFP) K090252; K083581; K043484 Medtronic CD Horizon Spinous Process P/ate K032037 Technological The technologi… | 2009 |
| * | K043484 | Lanx Spinal Fixation SystemSummary page 2…510(k) Summary Page 2 of 2 Lonx Spinous Process Fusion Plate (SPFP) K090252; K083581; K043484 Medtronic CD Horizon Spinous Process P/ate K032037 Technological The technological chara… | 2005 |
| * | K032037 | CD Horizon (Addition of Spinous Process Plate)Summary page 2…of 2 Lonx Spinous Process Fusion Plate (SPFP) K090252; K083581; K043484 Medtronic CD Horizon Spinous Process P/ate K032037 Technological The technological characteristics of the Integra Spinous Process device are the Characteristics:… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173334 | SeaSpine Spinous Process System | 2018 | 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 9 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K173334 (SeaSpine Orthopedics Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100407.
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?
Integra Spinous Process System is a posterior non-pedicle supplemental fixation system 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)
*spinal tumor
The device is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121924: Integra Interspinous Process System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121924
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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