510(k) Report

510(k) · Cleared

Cleared

Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate

K233527510(k) SpecialCleared Nov 29, 202328-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 Simplicity, LLC · PEK Spinous Process Plate

Cleared on Nov 29, 2023 as substantially equivalent to K221023 (Spinal Simplicity, LLC, 2022) after a 28-day review. Its family tree reaches back 15 generations to 1999. 2 later devices descend from it.

Decided
Nov 29, 2023
Review
28 days
Class
Class II
Product code
PEK
Recalls
None
Predicates
1

Its longest line of descent runs back 15 generations to K990745 (1999). 46 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 5 other ancestors2011: 3 other ancestors2007: 1 other ancestor2008: 2 other ancestors2005: 2 other ancestors2003: 3 other ancestors2012: 1 other ancestor2010: 2 other ancestors2004: 1 other ancestor2000: 3 other ancestors2001: 3 other ancestors1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1978: 1 other ancestor2024: 1 descendant cleared2025: 1 descendant clearedK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999K992739 · Click'x · Synthes Spine · 2000 · recalledK052123 · Synthes Pangea System · Synthes (Usa) · 2005K082572 · Uss Iliosacral, Uss Polyaxial · Synthes Spine · 2008×2: 2 generations cleared close together, K091445 (2010), K101471 (2010) K122509 · Vertiflex Spinous Process Fixation Plate · Vertiflex, Inc. · 2012K132968 · Univise Spinous Process Fixation Plate (35MM, 40MM) · Stryker Spine · 2013K140046 · Spinous Process Fusion (SPF) Plate · Spinal Simplicity, LLC · 2015K151741 · HA Minuteman G3 MIS Fusion Plate · Spinal Simplicity, LLC · 2015K163428 · HA Minuteman G3-R MIS Fusion Plate · Spinal Simplicity · 2017K200066 · Posterior Fusion Plate, HA Posterior Fusion Plate · Spinal Simplicity, LLC · 2020×3: 3 generations cleared close together, K212781 (2021), K211880 (2022), K221023 (2022) 19801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 7 other ancestors4 generations back: 6 other ancestors5 generations back: 6 other ancestors6 generations back: 10 other ancestors7 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K221023 · Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 · Spinal Simplicity, LLC · 2022K211880 · Minuteman G5 MIS Fusion Plate · Spinal Simplicity, LLC · 2022K212781 · Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate · Spinal Simplicity, LLC · 2021K200066 · Posterior Fusion Plate, HA Posterior Fusion Plate · Spinal Simplicity, LLC · 2020K163428 · HA Minuteman G3-R MIS Fusion Plate · Spinal Simplicity · 2017K151741 · HA Minuteman G3 MIS Fusion Plate · Spinal Simplicity, LLC · 2015K140046 · Spinous Process Fusion (SPF) Plate · Spinal Simplicity, LLC · 2015K132968 · Univise Spinous Process Fixation Plate (35MM, 40MM) · Stryker Spine · 2013K122509 · Vertiflex Spinous Process Fixation Plate · Vertiflex, Inc. · 2012K101471 · Axle Interspinous Fusion System · X-Spine Systems, Inc. · 2010 · recalledK091445 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2010K082572 · Uss Iliosacral, Uss Polyaxial · Synthes Spine · 2008K052123 · Synthes Pangea System · Synthes (Usa) · 2005K992739 · Click'x · Synthes Spine · 2000 · recalledK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999−15−10−50
  1. Root · 15 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 11 generations between
  3. 3 generations backK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
  4. 2 generations backK211880 Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC · 2022
  5. 1 generation backK221023 Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1)…Spinal Simplicity, LLC · 2022
  6. This deviceK233527 Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate…Spinal Simplicity, LLC · 2023
  7. Descendant · cites it directly · 1 of its ownK234051 Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate…Spinal Simplicity, LLC · 2024
  8. Descendant · 2 generations on · 0 of its ownK253250 Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC · 2025
Show all 15 generations
  1. Root · 15 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 14 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
  3. 13 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
  4. 12 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
  5. 11 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
  6. 10 generations backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
  7. 9 generations backK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
  8. 8 generations backK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
  9. 7 generations backK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
  10. 6 generations backK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
  11. 5 generations backK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
  12. 4 generations backK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
  13. 3 generations backK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
  14. 2 generations backK211880 Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC · 2022
  15. 1 generation backK221023 Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1)…Spinal Simplicity, LLC · 2022
  16. This deviceK233527 Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate…Spinal Simplicity, LLC · 2023

Most influential descendants

Showing 2 of 2 · See all
  • K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC · 2024 · cites it directly1descendant
  • K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K990745Modification to Synthes Universal Spinal SystemSynthes Spine1999—
−14K992739Click'xSynthes Spine20001
−13K052123Synthes Pangea SystemSynthes (Usa)2005—
−12K082572Uss Iliosacral, Uss PolyaxialSynthes Spine2008—
−11K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010—
−10K101471Axle Interspinous Fusion SystemX-Spine Systems, Inc.20101
−9K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.2012—
−8K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine2013—
−7K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC2015—
−6K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC2015—
−5K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity2017—
−4K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC2020—
−3K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion…Spinal Simplicity, LLC2021—
−2K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC2022—
−1K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman…Spinal Simplicity, LLC2022—
0 (this device)K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA…Spinal Simplicity, LLC2023—
+1K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA…Spinal Simplicity, LLC2024—
+2K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199620
199710
199810
200030
200130
200330
200410
200520
200710
200820
201020
201130
201210
201350

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202510
FIG. 1 — Lineage of K233527, 1999–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (1)

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
*K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…
Summary page 5
…ber 888.3050 Product Code PEK I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221023 Minuteman MIS Fusion Plate Implants PEK Device Description Summary 21 CFR 807.92(a)(4) The Minuteman MIS Fusion Plate Implants c…
Spinal Simplicity, LLC2022—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241

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 24 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
  • 4 of the 46 ancestors have a recall of any class.
  • Of its descendants, K234051 (Spinal Simplicity, LLC, 2024) has gone furthest, with 1 descendant of its own.

How does its category compare?

All PEK devices

PEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: * Lumbar spinal stenosis; * degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc…

Read the full statement (435 words)

The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

* Lumbar spinal stenosis;

* degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or

* spondylolisthesis.

The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman G1 (Posterior Fusion Plate/HA Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

* Lumbar spinal stenosis;

* degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or

* spondylolisthesis.

The Minuteman G1 (Posterior Fusion Plate/HA Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

* Lumbar spinal stenosis;

* degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or

* spondylolisthesis.

The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

* Lumbar spinal stenosis;

* degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or

* spondylolisthesis.

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Spinal Simplicity, LLC

15 FDA decisions under this applicant name. See the company

  • 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
  • K250001Patriot SI Implant SystemSpinal Simplicity, LLC · 2025
  • K240592Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC · 2024
  • K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC · 2024

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
  • K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine · 2023
  • K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc. · 2023

https://510kreport.com/device/K233527 · printed Nov 6, 2026

Cite this page

510(k) Report. “K233527: Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233527

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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