# K081395: Solitaire Peek-Optima Anterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Jun 25, 2008 after 37 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: 5 generations back to K010530 (2001). 9 ancestors in all.
854 later devices descend from it; 8 cite it directly.
1 of 864 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 1.
- K080758: Avs PL Peek Spacers, Models 48351 and 48353, Stryker Corp. (2008) Summary page 1.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 1.

## Most influential descendants
- K083475: Lucent Magnum (2009), 834 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own
- K123045: Brigade Standalone System (2013), 696 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K101310: VU Apod Intervertebral Body Fusion Device (2010), 480 descendants of its own

## Indications for use
The Solitaire™ PEEK-Optima® 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 1 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/K081395
Methodology: https://510kreport.com/methodology