Solitaire Anterior Spinal System
510(k) K081501
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081501 | Date2 Jul 2008 | StatusActive |
Recalls
-
- Terminated Z-1253-2016
Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OVD
- FDA applicant
- Biomet Spine
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Solitaire Anterior Spinal System is an intervertebral body fusion device designed for anterior spinal fixation. It consists of a titanium alloy spacer with radiographic markers and three cancellous bone screws, intended to restore spinal height, achieve decompression, and provide immediate mechanical stability during fusion procedures. The device is classified as an Orthopedic Intervertebral Fusion Device with Integrated Fixation and is specifically indicated for use in the lumbosacral spine.
This system is supplied sterile and intended for single-use. It is implanted surgically into the intervertebral body space alongside bone graft material, requiring no additional fixation hardware beyond the included screws. The device is MRI-unsafe due to its metallic construction and must be handled with appropriate surgical precautions. Storage and handling follow standard orthopedic implant protocols, and its regulatory status includes FDA 510(k) clearance under K081501.
Other devices from Biomet Spine LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Solitaire Anterior Spinal System used for?
The Solitaire Anterior Spinal System is designed for anterior spinal fusion in the lumbosacral spine. It helps restore spinal height, provides immediate mechanical stability, and achieves decompression during surgical procedures. The device is specifically intended for intervertebral body fusion, where it is implanted alongside bone graft material to support spinal alignment and promote fusion.
How is the Solitaire Anterior Spinal System supplied and prepared for use?
The system is supplied sterile and intended for single-use only. It includes a titanium alloy spacer with radiographic markers and three cancellous bone screws. Before use, the device must be handled with standard surgical precautions, as it is MRI-unsafe due to its metallic construction. Follow manufacturer guidelines for unpacking and preparation to ensure sterility and proper handling.
Is the Solitaire Anterior Spinal System reusable or single-use?
This device is explicitly intended for single-use only. After implantation, it should not be reused or reprocessed. The sterile packaging ensures safety for one surgical procedure, and reuse could compromise patient safety or device integrity.
What storage and handling precautions should be taken for the Solitaire Anterior Spinal System?
The device must be stored according to standard orthopedic implant protocols to maintain sterility and integrity. Keep it in its original packaging until ready for use, and handle it with sterile techniques in the operating room. Avoid exposure to moisture, contamination, or physical damage, as these could compromise its performance or sterility.
Does the Solitaire Anterior Spinal System require additional fixation hardware?
No, the Solitaire Anterior Spinal System includes all necessary fixation hardware—three cancellous bone screws—so no additional components are required for implantation. The screws are integrated into the design to secure the titanium spacer within the intervertebral space, providing stability during fusion.