Bonecam Suture Anchor
510(k) K193108
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193108 | Date26 Mar 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MBI
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bonecam Suture Anchor is a Fastener, Fixation, Nondegradable, Soft Tissue device, classified under product code MBI. It is designed for securing ligament, tendon, bone, or soft tissue to bone in orthopedic applications, including the knee, shoulder, foot/ankle, elbow, and other joints. Constructed from non-degradable materials, it provides stable fixation for soft tissue attachment procedures. The device is intended for use in surgical settings where secure anchoring is required to restore joint function or stability.
The Bonecam Suture Anchor is supplied as a single-use device with a shelf life of 2 years. It is fabricated from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (ASTM F2026) and is regulated under FDA 510(k) clearance (K193108) as a Class II – Special Controls device. Sterility and packaging details are not specified but are typically handled per manufacturer guidelines for surgical implants. Its design adheres to orthopedic fixation standards for soft tissue applications.
Other devices from Valeris Medical, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Bonecam Suture Anchor used for in orthopedic surgery?
The Bonecam Suture Anchor is designed to securely attach soft tissues—such as ligaments, tendons, or other soft tissue—to bone in orthopedic procedures. It is specifically intended for restoring joint function or stability in areas like the knee, shoulder, foot/ankle, elbow, and other joints where stable fixation is critical.
What materials is the Bonecam Suture Anchor made from, and why does that matter?
The Bonecam Suture Anchor is constructed from Solvay Zeniva ZA-500, ZA-600, or ZA-600 CF30 PEEK (compliant with ASTM F2026). PEEK (polyether ether ketone) is chosen for its biocompatibility, durability, and resistance to wear or degradation over time, ensuring long-term stability for soft tissue fixation without the need for biodegradation.
Is the Bonecam Suture Anchor single-use or reusable, and how should it be stored?
The Bonecam Suture Anchor is intended for single-use only, adhering to standard surgical implant protocols. It has a shelf life of 2 years from manufacture, and storage conditions should follow manufacturer guidelines for non-degradable orthopedic devices to maintain sterility and integrity until use.
What regulatory clearance does the Bonecam Suture Anchor hold, and what does that mean for clinicians?
The Bonecam Suture Anchor holds FDA 510(k) clearance (K193108) under Class II – Special Controls, meaning it has been deemed substantially equivalent to a legally marketed predicate device. This clearance confirms it meets FDA standards for safety and effectiveness as a non-degradable fixation device for soft tissue attachment in orthopedic surgeries.
Are there different sizes or models of the Bonecam Suture Anchor, and how are they selected?
While the provided data does not specify exact sizes or models, suture anchors like the Bonecam are typically available in varying diameters or lengths to accommodate different anatomical sites and tissue thicknesses. Selection is based on surgeon preference, patient anatomy, and the specific surgical procedure—such as knee reconstruction or shoulder stabilization—to ensure proper fixation.