510(k) · Cleared
ClearedReliance Interspinous Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Medical Systems, LLC · PEK Spinous Process Plate
Cleared on Apr 2, 2015 as substantially equivalent to K133363 (Ldr Spine USA, Inc., 2014) and 5 other predicates after a 233-day review. Its family tree reaches back 8 generations to 2004.
- Decided
- Apr 2, 2015
- Review
- 233 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). No later device cites it as a predicate yet.
- 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 deviceK142217 Reliance Interspinous Plate SystemReliance Medical Systems, LLC · 2015
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) | K142217 | Reliance Interspinous Plate System | Reliance Medical Systems, LLC | 2015 | — |
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 |
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 5…terilization Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Manufacturer Predicate Type Name K133363 Interspinous Posterior Fixation System InterBRIDGE Additional K073278, Affix Spinous Proce… | 2014 |
| * | K073278 | Spinous Process Plate SystemSummary page 5…Manufacturer Predicate Type Name K133363 Interspinous Posterior Fixation System InterBRIDGE Additional K073278, Affix Spinous Process Plate System NuVasive® Additional K131238 K123093 StabiLink™… | 2008 |
| * | K131238 | Affix Spinous Process Plate SystemSummary page 5…Interspinous Posterior Fixation System InterBRIDGE Additional K073278, Affix Spinous Process Plate System NuVasive® Additional K131238 K123093 StabiLink™ MIS Spinal Fixation Southern Spine Additional System K1… | 2013 |
| * | K123093 | Stabilink Mis Spinal Fixation SystemSummary page 5…pinous Posterior Fixation System InterBRIDGE Additional K073278, Affix Spinous Process Plate System NuVasive® Additional K131238 K123093 StabiLink™ MIS Spinal Fixation Southern Spine Additional System K100354… | 2012 |
| * | K100354 | Primal OK Interspinous Fusion SystemSummary page 5…NuVasive® Additional K131238 K123093 StabiLink™ MIS Spinal Fixation Southern Spine Additional System K100354 PrimaLOK™ Interspinous Fusion OsteoMed Primary System K122509… | 2010 |
| * | K122509 | Vertiflex Spinous Process Fixation PlateSummary page 5…Additional System K100354 PrimaLOK™ Interspinous Fusion OsteoMed Primary System K122509 Spinous Process Fixation Plate VertiFlex® Additional PERFORMANCE DATA The Reliance Interspinous… | 2012 |
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 11 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 43 ancestors have a recall of any class.
- 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. 2015, 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 Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1-S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following:
- degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- tumors
This device is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142217: Reliance 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/K142217
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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