510(k) · Cleared
ClearedPrecision Spine Interspinous 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 May 4, 2016 as substantially equivalent to K151863 (Precision Spine, Inc., 2015) and 3 other predicates after a 65-day review. Its family tree reaches back 10 generations to 2004.
- Decided
- May 4, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K033826 (2004). 49 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 10 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 6 generations between
- 3 generations backK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
- 2 generations backK142378 Interspinous Plate SystemPrecision Spine, Inc. · 2014
- 1 generation backK151863 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015
- This deviceK160568 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 9 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- 8 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
- 7 generations backK103237 Lanx Spinal SystemLanx, Inc. · 2011
- 6 generations backK120399 Lanx Spinal Fixation SystemLanx, LLC · 2012
- 5 generations backK121940 Lanx Spinal Fixation SystemLanx, Inc. · 2012
- 4 generations backK123093 Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
- 3 generations backK133363 Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
- 2 generations backK142378 Interspinous Plate SystemPrecision Spine, Inc. · 2014
- 1 generation backK151863 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2015
- This deviceK160568 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −9 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| −8 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| −7 | K103237 | Lanx Spinal System | Lanx, Inc. | 2011 | — |
| −6 | K120399 | Lanx Spinal Fixation System | Lanx, LLC | 2012 | — |
| −5 | K121940 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | — |
| −4 | K123093 | Stabilink Mis Spinal Fixation System | Southern Spine, LLC | 2012 | — |
| −3 | K133363 | Interbridge Interspinous Posterior Fixation System | Ldr Spine USA, Inc. | 2014 | — |
| −2 | K142378 | Interspinous Plate System | Precision Spine, Inc. | 2014 | — |
| −1 | K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2015 | — |
| 0 (this device) | 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 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K151863 | Precision Spine Interspinous Plate SystemSummary page 5… Structural support mechanism Sterilization Table 5-1: Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate K151863, K142378 Interspinous Plate System Precision Spine Primary K093438, K112595 Coflex-F Implant System Para… | 2015 |
| * | K142378 | Interspinous Plate SystemSummary page 5…ructural support mechanism Sterilization Table 5-1: Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate K151863, K142378 Interspinous Plate System Precision Spine Primary K093438, K112595 Coflex-F Implant System Paradigm Spin… | 2014 |
| * | K093438 | Paradigm Interspinous Fusion PlateSummary page 5…ices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate K151863, K142378 Interspinous Plate System Precision Spine Primary K093438, K112595 Coflex-F Implant System Paradigm Spine, LLC The subject device differs from the previously cleared version o… | 2010 |
| * | K112595 | Coflex-FSummary page 5…k Number Trade or Proprietary or Model Name Manufacturer Predicate K151863, K142378 Interspinous Plate System Precision Spine Primary K093438, K112595 Coflex-F Implant System Paradigm Spine, LLC The subject device differs from the previously cleared version of the dev… | 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 12 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 5 of the 49 ancestors have a recall of any class.
- 1 other device also cites its predicate K151863.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 as stated in the FDA summary.
https://510kreport.com/device/K160568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160568: Precision Spine 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/K160568
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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