# K140564: BN Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey USA, Inc.
- Decided: Jun 5, 2014 after 92 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: 3 generations back to P950002 (1996). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110067: LP Cage, Medyssey Co, Ltd. (2011) Summary page 1.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 1.

## Most influential descendants
- K172756: Varian cage (2017), 1 descendant of its own
- K203327: VERTACONNECT TLIF Cage (2021), 0 descendants of its own
- K170389: TAURUS PEEK Cage System (2017), 0 descendants of its own

## Indications for use
The BIN Cage is 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 bane.

Source page: https://510kreport.com/device/K140564
Methodology: https://510kreport.com/methodology