# K202380: Born PT-LIF Cage HA

- Pathway: 510(k) (Traditional)
- Applicant: Spineworxx AG
- Decided: Feb 19, 2021 after 183 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: 13 generations back to K841189 (1984). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151785: Px HA PEEK IBF System, Innovasis, Inc. (2015) Summary page 4.
- K130699: Aleutian Spinal System, K2m, Inc. (2013) Summary page 4.

## Indications for use
The Born PT-LIF Cage HA is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels of the spine from L2 to S1. These DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. These implants may be implanted in open surgery via a posterior or transforaminal approach. These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K202380
Methodology: https://510kreport.com/methodology