# 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

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Simplicity, LLC
- Decided: Dec 15, 2021 after 105 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K990745 (1999). 43 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200066: Posterior Fusion Plate, HA Posterior Fusion Plate, Spinal Simplicity, LLC (2020) Summary page 7.
- K151741: HA Minuteman G3 MIS Fusion Plate, Spinal Simplicity, LLC (2015) Summary page 7.
- K140046: Spinous Process Fusion (SPF) Plate, Spinal Simplicity, LLC (2015) Summary page 7.
- K163428: HA Minuteman G3-R MIS Fusion Plate, Spinal Simplicity (2017) Summary page 7.

## Most influential descendants
- K211880: Minuteman G5 MIS Fusion Plate (2022), 4 descendants of its own
- K221023: Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 (2022), 3 descendants of its own
- 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 (2023), 2 descendants of its own
- K234051: 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 (2024), 1 descendant of its own
- K253250: Minuteman® G6 MIS Fusion Plate (2025), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K212781
Methodology: https://510kreport.com/methodology