ANCHORMAN Tibial Ligament Fixation Device
by Summit Medical Ltd United Kingdom 510(k)
510(k) K170388 Product code MBI
Overview
The ANCHORMAN Tibial Ligament Fixation Device is a fastener, fixation, nondegradable, soft tissue device, classified under FDA regulation 888.3040. It is designed as a cortical tibial ligament fixation system, featuring a sterile, double-pouched Polyether ether ketone (PEEK) loop with two petals that rest on the cortical bone of the tibia. This device is intended for orthopedic applications, providing secure fixation for ligamentous structures in the tibia.
The device is supplied as a single-use, sterile product, packaged in a double pouch. It is intended for use in orthopedic surgical settings and adheres to FDA 510(k) clearance (K170388) under the Traditional review pathway. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the specifications. The device’s design ensures compatibility with standard orthopedic surgical procedures without MRI safety restrictions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170388 | Date25 Jul 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MBI
- FDA applicant
- Summit Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Summit Medical Ltd
Questions
What is the ANCHORMAN Tibial Ligament Fixation Device used for?
The ANCHORMAN Tibial Ligament Fixation Device is designed for orthopedic applications to provide secure fixation of ligamentous structures on the cortical bone of the tibia. Its double-pouched Polyether ether ketone (PEEK) loop with two petals is intended to stabilize ligaments during surgical procedures, ensuring reliable attachment without degrading over time.
How is the ANCHORMAN Tibial Ligament Fixation Device supplied and packaged?
The device is supplied as a single-use, sterile product in a double-pouched packaging. This ensures sterility and readiness for immediate use in orthopedic surgical settings, minimizing contamination risks and simplifying intraoperative workflow.
Is the ANCHORMAN Tibial Ligament Fixation Device reusable or single-use?
The device is explicitly intended for single-use only. Its sterile packaging and non-degradable PEEK material are optimized for one-time surgical application, reducing the risk of cross-contamination and ensuring consistent performance per procedure.
What materials is the ANCHORMAN Tibial Ligament Fixation Device made from?
The device is constructed from Polyether ether ketone (PEEK), a non-degradable polymer known for its strength, biocompatibility, and stability in orthopedic applications. PEEK’s properties make it suitable for cortical bone fixation while avoiding MRI safety concerns.
How should the ANCHORMAN Tibial Ligament Fixation Device be stored?
The device should be stored in its original, unopened double-pouched packaging to maintain sterility. Keep it in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Avoid exposure to chemicals or contaminants that could compromise the integrity of the PEEK material or packaging.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K170388