# K163428: HA Minuteman G3-R MIS Fusion Plate

- Pathway: 510(k) (Special)
- Applicant: Spinal Simplicity
- Decided: Feb 2, 2017 after 58 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: 10 generations back to K990745 (1999). 41 ancestors in all.
7 later devices descend from it; 3 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)
- K151741: HA Minuteman G3 MIS Fusion Plate, Spinal Simplicity, LLC (2015) Summary page 4.

## Most influential descendants
- K200066: Posterior Fusion Plate, HA Posterior Fusion Plate (2020), 6 descendants of its own
- 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 (2021), 5 descendants of its own
- 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

## Indications for use
The 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: x degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); x spondylolisthesis; x trauma (i.e., fracture or dislocation); and/or x tumor. The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for stand-alone use. The HA Minuteman G3-R MIS Fusion Plate may be implanted via a minimally invasive lateral approach (L1-S1).

Source page: https://510kreport.com/device/K163428
Methodology: https://510kreport.com/methodology