# K250667: DeGen Medical Patient Specific Implant (PSI) System

- Pathway: 510(k) (Special)
- Applicant: Degen Medical
- Decided: Apr 4, 2025 after 30 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 33 generations back to K841189 (1984). 1,372 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 1,374 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241077: DeGen Medical Patient Specific Implant (PSI) System, Degen Medical (2024) Summary page 6.

## Most influential descendants
- K251829: DeGen Medical Patient Specific Implant (PSI) System (2025), 0 descendants of its own

## Indications for use
Solar-S™ PSI (Anterior, Standalone, With Integrated Fixation) and Solar- A™ PSI Spacers (Anterior, Non-Standalone, With Integrated Fixation): The Solar-S™ PSI (Standalone) and Solar-A™ PSI (Non-Standalone, With Integrated Fixation) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) of the lumbosacral spine (L1-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-S™ PSI and Solar-A™ PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. Solar-S™ PSI Used with Screws or Tusks: When used with three (3) screws, Solar-S™ PSI Spacers devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels. When used with three (3) tusks, interbody devices must always be used with supplemental fixation and may be used at one or more levels. Hyperlordotic interbody devices (>20° lordosis) used with screws or tusks, must always be used with supplemental fixation, and may be used at one or more levels. When used with supplemental fixation, all Solar-S™ PSI Spacers used with screws or tusks may be used at one or more levels. Solar-A™ PSI: These devices are intended to be used at one or more levels with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. Solar-M™ PSI Spacers (Anterior, Without Integrated Fixation): Solar-M™ PSI Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-M™ PSI Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation. Impulse™ PSI Spacers (Posterior / Transforaminal): The Impulse™ PSI is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or more levels from L1-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse™ PSI is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.

Source page: https://510kreport.com/device/K250667
Methodology: https://510kreport.com/methodology