# K211474: Kleiner KG2 System

- Pathway: 510(k) (Traditional)
- Applicant: BAAT Medical Products B.V.
- Decided: Sep 14, 2021 after 125 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: 23 generations back to K841189 (1984). 352 ancestors in all.
No later device cites it as a predicate yet.
1 of 353 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181347: Aries® Lumbar Interbodies, Osseus Fusion Systems, LLC (2018) Summary page 4.
- K193203: MOJAVE Expandable Interbody System, K2m, Inc. (2020) Summary page 4.
- K173025: NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System, Nu Vasive, Incorporated (2018) Summary page 4.

## Indications for use
The KG2 implant is indicated for transforaminal and posterior interbody fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The KG2 implant is used to facilitate interbody fusion in the lumbar spine from L2 to SI using autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The interbody fusion devices are intended to be used with FDA-cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.

Source page: https://510kreport.com/device/K211474
Methodology: https://510kreport.com/methodology