510(k) Report

510(k) · Cleared

Cleared

Spinal Elements' Spinous Process Plate System

K160465510(k) TraditionalCleared Jul 28, 2016160-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spinal Elements, Inc. · PEK Spinous Process Plate

Cleared on Jul 28, 2016 as substantially equivalent to K151863 (Precision Spine, Inc., 2015) and 2 other predicates after a 160-day review. Its family tree reaches back 10 generations to 2004.

Decided
Jul 28, 2016
Review
160 days
Class
Class II
Product code
PEK
Recalls
None
Predicates
3

Its longest line of descent runs back 10 generations to K040583 (2004). 90 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2010: 4 other ancestors2014: 2 other ancestors2013: 2 other ancestors2007: 3 other ancestors2005: 7 other ancestors2012: 5 other ancestors2011: 4 other ancestors2008: 4 other ancestors2003: 6 other ancestors2009: 4 other ancestors2004: 10 other ancestors2000: 7 other ancestors1996: 3 other ancestors2001: 7 other ancestors1998: 2 other ancestors1997: 1 other ancestor1978: 1 other ancestor2006: 1 other ancestor2002: 3 other ancestors1999: 2 other ancestors1984: 1 other ancestor×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K092325 (2009) K123246 · CD Horizon Spire Z Spinal System · Medtronic Sofamor Danek · 20121980199020002010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 10 other ancestors4 generations back: 14 other ancestors5 generations back: 24 other ancestors6 generations back: 16 other ancestors7 generations back: 8 other ancestors8 generations back: 2 other ancestors K123246 · CD Horizon Spire Z Spinal System · Medtronic Sofamor Danek · 2012K092325 · Modification to:CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009K091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50
  1. Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 6 generations between
  3. 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  4. 2 generations backK092325 Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
  5. 1 generation backK123246 CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek · 2012
  6. This deviceK160465 Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016
Show all 10 generations
  1. Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 9 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 8 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 7 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 6 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 5 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 4 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 2 generations backK092325 Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009
  10. 1 generation backK123246 CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek · 2012
  11. This deviceK160465 Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−9K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−8K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−7K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−6K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−5K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−4K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−2K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2009—
−1K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek2012—
0 (this device)K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199630
199710
199820
199920
200070
200170
200230
200360
2004100
200570
200610
200730
200840
200940
201040
201140
201250
201320
201420
201510
FIG. 1 — Lineage of K160465, 2004–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253250 Minuteman® G6 MIS Fusion Platescore 15.2 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K151863Precision Spine Interspinous Plate System
Summary page 5
…ous Process Plate System is not intended for stand-alone use. Substantial Equivalence The subject device is substantially equivalent to the predicate devices cleared in K151863 Reli SP Spinous Plating System (PRIMARY), K123246 CD HORIZON SPIRE and K100354 PrimaLOK sp Interspinous Fusion System. Technolog…
Precision Spine, Inc.2015—
*K123246CD Horizon Spire Z Spinal System
Summary page 5
…-alone use. Substantial Equivalence The subject device is substantially equivalent to the predicate devices cleared in K151863 Reli SP Spinous Plating System (PRIMARY), K123246 CD HORIZON SPIRE and K100354 PrimaLOK sp Interspinous Fusion System. Technological Characteristics The subject device has equiva…
Medtronic Sofamor Danek2012—
*K100354Primal OK Interspinous Fusion System
Summary page 5
…valence The subject device is substantially equivalent to the predicate devices cleared in K151863 Reli SP Spinous Plating System (PRIMARY), K123246 CD HORIZON SPIRE and K100354 PrimaLOK sp Interspinous Fusion System. Technological Characteristics The subject device has equivalent technological characteri…
Osteomed LP2010—

Also cleared against K151863: 1 other device →

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 4 companies; a new generation was cleared every 5 months on median.
  • 9 of the 90 ancestors have a recall of any class.
  • 1 other device also cites its predicate K151863.

How does its category compare?

All PEK devices

PEK 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

2013: 102014: 82015: 62016: 42017: 32018: 42020: 22021: 22022: 32023: 42024: 12025: 12026 (partial year): 1
2007high 10 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PEK

60in 2023

2013: 118 days median2014: 120 days median2015: 166 days median2016: 176 days median2017: 94 days median2018: 69 days median2022: 135 days median2023: 60 days median
2007high 176 (2016) · low 60 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PEK

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PEK

3in 2025

2011: 22014: 22015: 32018: 22019: 42020: 22021: 172022: 112023: 82024: 52025: 3
2007high 17 (2021) · low 0 (2007)2025

MAUDE reports naming product code PEK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—02
20120—00
20131011800
2014812002
2015616603
2016417600
201739400
201846902
20190—04
20202—02
20212—117
20223135011
202346008
20241—05
20251—03
20261—0—

What is it indicated for?

Spinal Elements’ Spinous Process 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. Spinal Elements’ Spinous Process Plate System is not intended for stand-alone use.

Indications for use as stated in the FDA summary.

Also cleared against K151863

1 other device cites the same predicate.

  • K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016

More from Spinal Elements, Inc.

49 FDA decisions under this applicant name. See the company

  • K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc. · 2026
  • K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc. · 2026
  • K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc. · 2026
  • K242527The Karma® Fixation SystemSpinal Elements, Inc. · 2025
  • K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025

Recent decisions in PEK

The PEK category page

  • K261607Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA…Spinal Simplicity, LLC · 2026
  • K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC · 2025
  • K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman…Spinal Simplicity, LLC · 2024
  • K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA…Spinal Simplicity, LLC · 2023
  • K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine · 2023

https://510kreport.com/device/K160465 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160465: Spinal Elements' Spinous Process Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160465

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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