# K112696: Twin Peaks Lumbar Cage

- Pathway: 510(k) (Traditional)
- Applicant: Qualgenix, LLC
- Decided: Apr 18, 2012 after 216 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). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has 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 1.
- K101720: Juliet OL, Spineart (2010). Our reading of the summary gave K101710, FDA’s number for Luxatemp Ultra /Star (Dmg USA, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SpineArt Juliet Cage”.
- K080588: Scient'x Tribeca VBR, Scient'X USA, Inc. (2008) Summary page 1.

## Indications for use
The Qualgenix Twin Peaks Lumbar Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from 12 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Qualgenix Twin Peaks Lumbar Cage is to be used with supplemental fixation.

Source page: https://510kreport.com/device/K112696
Methodology: https://510kreport.com/methodology