# K170389: TAURUS PEEK Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey USA, Inc.
- Decided: Dec 14, 2017 after 309 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). 177 ancestors in all.
No later device cites it as a predicate yet.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140564: BN Lumbar Cage System, Medyssey USA, Inc. (2014) Summary page 4.
- K133216: Crescent Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 4.
- K081636: Peek-Optima Alif Spacer, Biomet Spine (2008) Summary page 4.
- K153782: NuVasive® Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 4.

## Indications for use
The TAURUS PEEK Cages are 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 at the involved level(s). It is indicated to be used with autograft bone.

Source page: https://510kreport.com/device/K170389
Methodology: https://510kreport.com/methodology