510(k) · Cleared
ClearedInterbridge Interspinous Posterior Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA, Inc. · PEK Spinous Process Plate
Cleared on Mar 7, 2014 as substantially equivalent to K100354 (Osteomed LP, 2010) and 3 other predicates after a 126-day review. Its family tree reaches back 7 generations to 2004. 5 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 126 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K033826 (2004). 19 ancestors in all, the oldest K032037 (2003). 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 6 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- 5 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
- 4 generations backK103237 Lanx Spinal SystemLanx, Inc. · 2011
- 3 generations backK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
- 2 generations backK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
- 1 generation backK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
- This deviceK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK142378 Interspinous Plate SystemPrecision Spine, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK151863 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK160465 Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK160568 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK142217 Reliance Interspinous Plate SystemReliance Medical Systems, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K142378Interspinous Plate SystemPrecision Spine, Inc. · 2014 · cites it directly3descendants
- K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015 · 2 generations on2descendants
- K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016 · 3 generations on0descendants
- K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016 · 2 generations on0descendants
- K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −6 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| −5 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| −4 | K103237 | Lanx Spinal System | Lanx, Inc. | 2011 | — |
| −3 | K120399 | Lanx Spinal Fixation System | Lanx, LLC | 2012 | — |
| −2 | K121940 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | — |
| −1 | K123093 | Stabilink Mis Spinal Fixation System | Southern Spine, LLC | 2012 | — |
| 0 (this device) | K133363 | Interbridge Interspinous Posterior Fixation System | Ldr Spine USA, Inc. | 2014 | — |
| +1 | K142378 | Interspinous Plate System | Precision Spine, Inc. | 2014 | — |
| +2 | K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2015 | — |
| +3 | K160465 | Spinal Elements' Spinous Process Plate System | Spinal Elements, Inc. | 2016 | — |
| +2 | K160568 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2016 | — |
| +1 | K142217 | Reliance Interspinous Plate System | Reliance Medical Systems, LLC | 2015 | — |
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 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K100354 | Primal OK Interspinous Fusion SystemSummary page 1…B ranch Predicate Devices: OsteoMed Spine PrimaLOKTM Interspinous Fusion System (K 100354) NuVasive Affix Spinous Process Plate (K073278,… | 2010 |
| * | K073278 | Spinous Process Plate SystemSummary page 1…terspinous Fusion System (K 100354) NuVasive Affix Spinous Process Plate (K073278, K1 31238) Southern Spine StabiLi… | 2008 |
| * | K131238 | Affix Spinous Process Plate SystemSummary page 1…System (K 100354) NuVasive Affix Spinous Process Plate (K073278, K1 31238) Southern Spine StabiLinkTM MIS Spinal Fixation System… | 2013 |
| * | K123093 | Stabilink Mis Spinal Fixation SystemSummary page 1…K1 31238) Southern Spine StabiLinkTM MIS Spinal Fixation System (K 123093) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The InterBRIDGE®K System is a posterior, non-pedicle supplemental… | 2012 |
What descends from it? (5)
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 5 companies; a new generation was cleared every 11 months on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K142378 (Precision Spine, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K100354.
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 InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (TI-SI). It is intended for plate fixation/attachment to 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)
* Spandylolisthesis
* Trauma (fracture or dislocation)
* Tumor
The InterBRIDGE®D system is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133363 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133363: Interbridge Interspinous Posterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133363
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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