# K120557: Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35

- Pathway: 510(k) (Special)
- Applicant: Biomet Spine & Bone Healing Technologies
- Decided: Mar 19, 2012 after 24 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 7 generations back to K010530 (2001). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081395: Solitaire Peek-Optima Anterior Spinal System, Biomet Spine (2008) Summary page 1.
- K082252: Independence Spacer, Globus Medical, Inc. (2008) Summary page 1.
- K082406: Expandable Peek-Optima Implant, Ebi, L.P. (2009) Summary page 1.

## Most influential descendants
- K130641: Logic Stand-Alone Intervertebral Body Fusion Device (2013), 0 descendants of its own

## Indications for use
The Solitaire® PEEK Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K120557
Methodology: https://510kreport.com/methodology