510(k) · Cleared
ClearedMinuteman® G6 MIS Fusion Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Simplicity, LLC · PEK Spinous Process Plate
Cleared on Dec 1, 2025 as substantially equivalent to K234051 (Spinal Simplicity, LLC, 2024) after a 63-day review. Its family tree reaches back 17 generations to 1999.
- Decided
- Dec 1, 2025
- Review
- 63 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K990745 (1999). 48 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 13 generations between
- 3 generations backK221023 Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1)…Spinal Simplicity, LLC · 2022
- 2 generations backK233527 Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate…Spinal Simplicity, LLC · 2023
- 1 generation backK234051 Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate…Spinal Simplicity, LLC · 2024
- This deviceK253250 Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC · 2025
Show all 17 generations
- Root · 17 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 16 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 15 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 14 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 13 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
- 11 generations backK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- 10 generations backK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- 9 generations backK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
- 8 generations backK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
- 7 generations backK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
- 6 generations backK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
- 5 generations backK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
- 4 generations backK211880 Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC · 2022
- 3 generations backK221023 Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1)…Spinal Simplicity, LLC · 2022
- 2 generations backK233527 Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate…Spinal Simplicity, LLC · 2023
- 1 generation backK234051 Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate…Spinal Simplicity, LLC · 2024
- This deviceK253250 Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −16 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −15 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −14 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −13 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K101471 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2010 | 1 |
| −11 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| −10 | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| −9 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
| −8 | K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015 | — |
| −7 | K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017 | — |
| −6 | K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020 | — |
| −5 | K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion… | Spinal Simplicity, LLC | 2021 | — |
| −4 | K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | 2022 | — |
| −3 | K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman… | Spinal Simplicity, LLC | 2022 | — |
| −2 | K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA… | Spinal Simplicity, LLC | 2023 | — |
| −1 | K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA… | Spinal Simplicity, LLC | 2024 | — |
| 0 (this device) | K253250 | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | 2025 | — |
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 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 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 K234051 Minuteman G5 MIS Fusion Plate; Minuteman…score 14.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Summary page 5…888.3050 Product Code(s) PEK | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K234051 Minuteman G5 MIS Fusion Plate PEK Device Description Summary 21 CFR 807.92(a)(4) The Minuteman G6 MIS Fusion Plate is a minimall… | 2024 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 48 ancestors have a recall of any class.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Spinal Simplicity Minuteman G6 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (L1-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…
Read the full statement (104 words)
The Spinal Simplicity Minuteman G6 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (L1-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 G6 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253250: Minuteman® G6 MIS Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253250
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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