# K093629: Solitaire and Solitaire Peek Anterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Mar 9, 2010 after 106 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010530 (2001). 31 ancestors in all.
143 later devices descend from it; 1 cites it directly.
0 of 175 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022143: Interpore Cross International Anterior Fixation Device (Afd), Interpore Cross Intl. (2003) Summary page 3.
- K062810: Solitaire Anterior Spinal System, Ebi, L.P. (2006) Summary page 3.
- K081501: Solitaire Anterior Spinal System, Biomet Spine (2008) Summary page 3.
- K081395: Solitaire Peek-Optima Anterior Spinal System, Biomet Spine (2008) Summary page 3.
- K070955: Acid Etched Lag Screws, Biomet Orthopedics, Inc. (2007) Summary page 3.
- K082874: Biodrive Cannulated Screw System, Biomet Trauma (2009) Summary page 3.

## Most influential descendants
- K113796: Solitaire-C Cervical Spacer System (2012), 142 descendants of its own
- K132029: Vault-C Intervertebral Body Fusion Device (2013), 108 descendants of its own
- K190546: NEXXT MATRIXX Stand Alone Cervical System (2019), 93 descendants of its own
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (2020), 72 descendants of its own
- K202812: IdentiTi Cervical Standalone Interbody System (2020), 67 descendants of its own

## Recalls of this device
- Apr 9, 2013 · Class II · Z-2292-2013: Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.

## Indications for use
The Solitaire™ and 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 L5 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. Additionally, the Solitaire™ Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K093629
Methodology: https://510kreport.com/methodology