510(k) · Cleared
ClearedPosterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R 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 15, 2021 as substantially equivalent to K200066 (Spinal Simplicity, LLC, 2020) and 3 other predicates after a 105-day review. Its family tree reaches back 12 generations to 1999. 5 later devices descend from it.
- Decided
- Dec 15, 2021
- Review
- 105 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K990745 (1999). 43 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations between
- 3 generations backK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
- 2 generations backK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
- 1 generation backK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
- This deviceK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
- Descendant · cites it directly · 4 of its ownK211880 Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC · 2022
- Descendant · cites it directly · 3 of its ownK221023 Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1)…Spinal Simplicity, LLC · 2022
- Descendant · 2 generations on · 2 of its ownK233527 Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate…Spinal Simplicity, LLC · 2023
- Descendant · 3 generations on · 1 of its ownK234051 Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate…Spinal Simplicity, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK253250 Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC · 2025
Show all 12 generations
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 10 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 9 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 8 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
- 6 generations backK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- 5 generations backK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- 4 generations backK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
- 3 generations backK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
- 2 generations backK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
- 1 generation backK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
- This deviceK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
Most influential descendants
Showing 5 of 5 · See all- K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC · 2022 · cites it directly4descendants
- K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC · 2022 · cites it directly3descendants
- K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC · 2023 · 2 generations on2descendants
- K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC · 2024 · 3 generations on1descendant
- K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −11 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −10 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −9 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −8 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K101471 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2010 | 1 |
| −6 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| −5 | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| −4 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
| −3 | K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015 | — |
| −2 | K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017 | — |
| −1 | K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020 | — |
| 0 (this device) | K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion… | Spinal Simplicity, LLC | 2021 | — |
| +1 | K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | 2022 | — |
| +1 | 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 | — |
| +3 | K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA… | Spinal Simplicity, LLC | 2024 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K200066 | Posterior Fusion Plate, HA Posterior Fusion PlateSummary page 7…ixation Orthosis, Class II Product codes: PEK Predicate Devices: Primary Predicate Device: • Spinal Simplicity’s Posterior Fusion Plate / HA Posterior Fusion Plate (K200066) Additional Predicate Devices: • Spinal Simplicity’s HA Minuteman G3 MIS Fusion Plate (K151741) • Spinal Simplicity’s Minu… | 2020 |
| * | K151741 | HA Minuteman G3 MIS Fusion PlateSummary page 7…pinal Simplicity’s Posterior Fusion Plate / HA Posterior Fusion Plate (K200066) Additional Predicate Devices: • Spinal Simplicity’s HA Minuteman G3 MIS Fusion Plate (K151741) • Spinal Simplicity’s Minuteman G3 MIS Fusion Plate (K140046) • Spinal Simplicity’s HA Minuteman G3-R MIS Fusion Plate (K1… | 2015 |
| * | K140046 | Spinous Process Fusion (SPF) PlateSummary page 7…late (K200066) Additional Predicate Devices: • Spinal Simplicity’s HA Minuteman G3 MIS Fusion Plate (K151741) • Spinal Simplicity’s Minuteman G3 MIS Fusion Plate (K140046) • Spinal Simplicity’s HA Minuteman G3-R MIS Fusion Plate (K163428) Device Description: The Minuteman devices consist of bil… | 2015 |
| * | K163428 | HA Minuteman G3-R MIS Fusion PlateSummary page 7…HA Minuteman G3 MIS Fusion Plate (K151741) • Spinal Simplicity’s Minuteman G3 MIS Fusion Plate (K140046) • Spinal Simplicity’s HA Minuteman G3-R MIS Fusion Plate (K163428) Device Description: The Minuteman devices consist of bilateral Plates and a Body/Post that connects the Plates, identical to t… | 2017 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 43 ancestors have a recall of any class.
- Of its descendants, K211880 (Spinal Simplicity, LLC, 2022) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K200066.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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 (493 words)
The Spinal Simplicity Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation); and/or
• tumor.
The Posterior Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Spinal Simplicity Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation); and/or
• tumor.
The Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation); and/or
• tumor.
The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).
The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
• spondylolisthesis;
• trauma (i.e., fracture or dislocation); and/or
• tumor.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212781 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212781: 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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212781
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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