510(k) Report

510(k) · Cleared

Cleared

PFX Spinous Process Fixation System

K132765510(k) TraditionalCleared Jul 14, 2014313-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

Innovasis, Inc. · PEK Spinous Process Plate

Cleared on Jul 14, 2014 as substantially equivalent to K032037 (Medtronic Sofamor Danek, 2003) and 3 other predicates after a 313-day review. Its family tree reaches back 10 generations to 2004.

Decided
Jul 14, 2014
Review
313 days
Class
Class II
Product code
PEK
Recalls
None
Predicates
4

Its longest line of descent runs back 10 generations to K040583 (2004). 55 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 3 other ancestors2009: 1 other ancestor2003: 4 other ancestors2008: 2 other ancestors2007: 3 other ancestors2005: 6 other ancestors2010: 1 other ancestor2004: 10 other ancestors1996: 1 other ancestor2006: 1 other ancestor2002: 3 other ancestors2000: 3 other ancestors1999: 1 other ancestor2001: 4 other ancestors1998: 1 other ancestor1984: 1 other ancestor×3: 3 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004) K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005×2: 2 generations cleared close together, K050809 (2005), K052187 (2005) K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K092325 · Modification to:CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009K123246 · CD Horizon Spire Z Spinal System · Medtronic Sofamor Danek · 201219801985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 7 other ancestors6 generations back: 13 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 deviceK132765 PFX Spinous Process Fixation SystemInnovasis, Inc. · 2014
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 deviceK132765 PFX Spinous Process Fixation SystemInnovasis, Inc. · 2014
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)K132765PFX Spinous Process Fixation SystemInnovasis, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199610
199810
199910
200030
200140
200230
200340
2004100
200560
200610
200730
200820
200910
201010
201330
FIG. 1 — Lineage of K132765, 2004–2014Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032037CD Horizon (Addition of Spinous Process Plate)
Summary page 1
…ode: PEK Review Panel: Orthopedic/87 Posterior Spine Devices Branch (P5DB) Substantially Equivalent Device: K032037, K123246 CD HORIZON® SPIRE TM Z Spinal System K090252…
Medtronic Sofamor Danek2003—
*K123246CD Horizon Spire Z Spinal System
Summary page 1
…Review Panel: Orthopedic/87 Posterior Spine Devices Branch (P5DB) Substantially Equivalent Device: K032037, K123246 CD HORIZON® SPIRE TM Z Spinal System K090252 Asp…
Medtronic Sofamor Danek2012—
*K090252Modification to: Lanx Spinal Fixation System
Summary page 1
…(P5DB) Substantially Equivalent Device: K032037, K123246 CD HORIZON® SPIRE TM Z Spinal System K090252 Aspen Tm Spinous Process Fixation System K133052 Affix Spinous Process Plate System Device D…
Lanx, Inc.2009—
*K133052Affix (R) Next Gen Spinous Process Plate System
Cleared while this submission was under review
Summary page 1
…SPIRE TM Z Spinal System K090252 Aspen Tm Spinous Process Fixation System K133052 Affix Spinous Process Plate System Device Description: The Innovasis® PFX h Posteri'or Spinous Fixation System…
Nuvasive, Inc.2013—

Also cleared against K032037: 11 other devices →

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 10 years and passes through 4 companies; a new generation was cleared every 5 months on median.
  • 6 of the 55 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K032037.

How does its category compare?

All PEK devices

PEK 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

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?

The Innovasis PFX Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T1-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior Spinous Fixation System is intended for use at one level, with bone graft material. The PFX Posterior Spinous Fixation…

Read the full statement (121 words)

The Innovasis PFX Posterior Spinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the posterior non-cervical spine (T1-S1) of skeletally mature patients. It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion. The PFX Posterior Spinous Fixation System is intended for use at one level, with bone graft material. The PFX Posterior Spinous Fixation System is indicated for use as an aid in immobilization and stabilization of spinal segments as an adjunct to fusion for treatment of the following conditions:

* Degenerative disc disease: Back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

* Trauma: fracture or dislocation

* Spondylolisthesis

* Tumor

Indications for use as stated in the FDA summary.

Also cleared against K032037

11 other devices cite the same predicate.

  • K141508Romeo 2 Pad Posterior Axial DeviceSpineart · 2014
  • K132191SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc. · 2013
  • K121924Integra Interspinous Process SystemSeaspine, Inc. · 2013
  • K123232Spineology Spinous Process PlateSpineology, Inc. · 2013
  • K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC · 2012
  • K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012

More from Innovasis, Inc.

33 FDA decisions under this applicant name. See the company

  • K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation…Innovasis, Inc. · 20251 recall
  • K250182Innovasis Navigation InstrumentsInnovasis, Inc. · 20251 recall
  • K241276Vector™ Pedicle Screw SystemInnovasis, Inc. · 20241 recall
  • K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023
  • K223511Excella Navigation InstrumentsInnovasis, Inc. · 2023

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/K132765 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132765: PFX Spinous Process Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132765

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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