510(k) · Cleared
ClearedInterspinous Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · PEK Spinous Process Plate
Cleared on Dec 18, 2014 as substantially equivalent to K133363 (Ldr Spine USA, Inc., 2014) and 5 other predicates after a 114-day review. Its family tree reaches back 8 generations to 2004. 3 later devices descend from it.
- Decided
- Dec 18, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K033826 (2004). 43 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 7 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- 6 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
- 5 generations backK103237 Lanx Spinal SystemLanx, Inc. · 2011
- 4 generations backK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
- 3 generations backK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
- 2 generations backK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
- 1 generation backK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
- This deviceK142378 Interspinous Plate SystemPrecision Spine, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK151863 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK160465 Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK160568 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015 · cites it directly2descendants
- K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016 · 2 generations on0descendants
- K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −7 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| −6 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| −5 | K103237 | Lanx Spinal System | Lanx, Inc. | 2011 | — |
| −4 | K120399 | Lanx Spinal Fixation System | Lanx, LLC | 2012 | — |
| −3 | K121940 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | — |
| −2 | K123093 | Stabilink Mis Spinal Fixation System | Southern Spine, LLC | 2012 | — |
| −1 | K133363 | Interbridge Interspinous Posterior Fixation System | Ldr Spine USA, Inc. | 2014 | — |
| 0 (this device) | K142378 | Interspinous Plate System | Precision Spine, Inc. | 2014 | — |
| +1 | K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2015 | — |
| +2 | K160465 | Spinal Elements' Spinous Process Plate System | Spinal Elements, Inc. | 2016 | — |
| +1 | K160568 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K133363 | Interbridge Interspinous Posterior Fixation SystemSummary page 6… Structural support mechanism Sterilization Table 5-1: Primary Predicate Device 510k Number Trade or Proprietary or Model Name Manufacturer K133363 InterBRIDGE Interspinous Posterior LDR Spine USA, Inc. Fixation System Table 5-2… | 2014 |
| * | K073278 | Spinous Process Plate SystemSummary page 6…SA, Inc. Fixation System Table 5-2: Additional Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer K073278, K131238 Affix Spinous Process Plate System NuVasive® K123093 StabiLink™ MIS Spinal Fixation System… | 2008 |
| * | K131238 | Affix Spinous Process Plate SystemSummary page 6…Fixation System Table 5-2: Additional Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer K073278, K131238 Affix Spinous Process Plate System NuVasive® K123093 StabiLink™ MIS Spinal Fixation System Southe… | 2013 |
| * | K123093 | Stabilink Mis Spinal Fixation SystemSummary page 6…redicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer K073278, K131238 Affix Spinous Process Plate System NuVasive® K123093 StabiLink™ MIS Spinal Fixation System Southern Spine K100354 PrimaLOK™ Interspinous Fusion Sy… | 2012 |
| * | K100354 | Primal OK Interspinous Fusion SystemSummary page 6…Manufacturer K073278, K131238 Affix Spinous Process Plate System NuVasive® K123093 StabiLink™ MIS Spinal Fixation System Southern Spine K100354 PrimaLOK™ Interspinous Fusion System OsteoMed K122509 Spinous Process Fixation Plate… | 2010 |
| * | K122509 | Vertiflex Spinous Process Fixation PlateSummary page 6…NuVasive® K123093 StabiLink™ MIS Spinal Fixation System Southern Spine K100354 PrimaLOK™ Interspinous Fusion System OsteoMed K122509 Spinous Process Fixation Plate VertiFlex® PERFORMANCE DATA The Precision Spine Interspinous Plate Syst… | 2012 |
What descends from it? (3)
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 6 companies; a new generation was cleared every 11 months on median.
- 3 of the 43 ancestors have a recall of any class.
- Of its descendants, K151863 (Precision Spine, Inc., 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K133363.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level 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), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142378: Interspinous Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142378
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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