# K252113: PRADO™ Lumbar Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Bethesda Medical Devices
- Decided: Aug 5, 2025 after 29 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). 1,289 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141443: Infront Lumbar Interbody Fusion System, Infront Medical, LLC (2014) Summary page 5.
- K241375: IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer, Alphatec Spine (2025) Summary page 5.
- K170395: Talos® Lumbar (HA) PEEK IBF Devices, Meditech Spine, LLC (2017) Summary page 5.

## Indications for use
The PRADO™ Lumbar Interbody Fusion System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis and/or stenosis at the involved level(s). Additionally, the Prado™ Lumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. It is indicated to be used with autograft bone and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. Additionally, the use of hyperlordotic devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.

Source page: https://510kreport.com/device/K252113
Methodology: https://510kreport.com/methodology