Threvo Anchor, Disposable Driver, Hi-Fi Sutures
510(k) K073481
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073481 | Date7 Jan 2008 | 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- Withdrawn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 Threvo Anchor is a suture anchor designed for orthopedic fixation, classified under the FDA’s orthopedic product code (MBI). It features a titanium implant pre-threaded with three non-absorbable #2 ultra-high-molecular-weight polyethylene sutures, enabling secure tissue attachment in bone. The device is intended for arthroscopic or mini-open shoulder procedures, particularly rotator cuff repairs, where precise fixation is critical. Its self-punching mechanism allows for insertion without pre-drilling, simplifying surgical workflows.
Supplied as a single-use, sterile device, the Threvo Anchor includes a disposable driver with a stainless steel shaft and ABS handle. It is regulated under FDA 510(k) clearance (K073481) as substantially equivalent to predicate devices, with no third-party review. The anchor is available in a 5.0 mm diameter configuration, as referenced in product codes like CF6160HB, and is intended for use in controlled surgical environments. Storage and handling must comply with sterile medical device protocols to maintain integrity.
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Questions
AI-generated answers, 1 Oct 2026
What is the Threvo Anchor designed for in orthopedic surgery?
The Threvo Anchor is specifically engineered for arthroscopic or mini-open shoulder procedures, particularly rotator cuff repairs. Its self-punching titanium design allows for secure tissue attachment in bone without requiring pre-drilling, making it ideal for cases where precise fixation is critical. The pre-threaded #2 ultra-high-molecular-weight polyethylene sutures ensure stable anchoring, streamlining the surgical workflow.
How is the Threvo Anchor supplied and what does the packaging include?
The Threvo Anchor is supplied as a single-use, sterile device. Each package includes the titanium anchor itself and a disposable driver with a stainless steel shaft and ABS handle. This combination ensures sterility and ease of use, as the driver is designed to work exclusively with the anchor for optimal performance during surgery.
Is the Threvo Anchor reusable or intended for single-use?
The Threvo Anchor is explicitly intended for single-use only. This design choice aligns with sterile medical device protocols, reducing the risk of cross-contamination and ensuring patient safety. The disposable driver further supports this single-use application, as it is not designed for reprocessing or reuse.
What size and model configurations are available for the Threvo Anchor?
The Threvo Anchor is currently available in a single diameter configuration: 5.0 mm. This size is referenced in product codes such as CF6160HB and is optimized for common orthopedic fixation needs in shoulder procedures. The anchor’s self-punching mechanism accommodates this specific diameter for reliable insertion.
How should the Threvo Anchor be stored to maintain its integrity?
The Threvo Anchor must be stored in accordance with sterile medical device protocols to preserve its integrity. This includes maintaining the original packaging until immediate preoperative use, protecting it from physical damage, and ensuring it remains in a clean, controlled environment. Proper storage prevents contamination and ensures the device remains ready for sterile surgical procedures.