# K170890: TELIX K Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Biedermann Motech GmbH & Co. KG
- Decided: Jun 2, 2017 after 67 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: 9 generations back to K841189 (1984). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081917: Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems, Depuy Spine, Inc. (2009) Summary page 5.

## Indications for use
The TELIX K Interbody System is indicated for use as intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone. These implants are intended for use with Biedermann Motech supplemental internal fixation products.

Source page: https://510kreport.com/device/K170890
Methodology: https://510kreport.com/methodology