# K242457: EARP Interbody System

- Pathway: 510(k) (Special)
- Applicant: Retropsoas Technologies, LLC
- Decided: Oct 7, 2024 after 49 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: 18 generations back to K841189 (1984). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212477: EARP Interbody System, Nvision Biomedical Technologies, Inc. (2022) Summary page 4.
- K193645: nva, nvp, and nvt, Nvision Biomedical Technologies, Inc. (2020) Summary page 4.

## Indications for use
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DOD patients may also have Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone to facilitate fusion and are implanted via a posterolateral approach.

Source page: https://510kreport.com/device/K242457
Methodology: https://510kreport.com/methodology