Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)
510(k) K231002
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231002 | Date7 Jun 2023 | 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- Withdrawn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 Javelot PK-S, PK-P, and PK-L suture anchors are bioabsorbable devices designed for soft tissue reattachment to bone. These anchors are classified as suture anchors and are intended for orthopedic applications, providing a secure fixation point for tendons, ligaments, or other soft tissues during surgical procedures. Their knotless variants eliminate the need for manual knot tying, simplifying implantation while maintaining stability. The anchors are engineered to integrate with bone over time, offering a temporary fixation solution that gradually resorbs as healing progresses.
These suture anchors are supplied sterile and intended for single-use in orthopedic surgeries, including procedures such as Bankart lesion repair and SLAP lesion fixation in the shoulder. They are classified under FDA product code MBI and were granted Substantially Equivalent (SESE) status via a Traditional 510(k) review by the Orthopedic (OR) Advisory Committee. The anchors are not MRI-safe and must be handled with sterile technique. Storage and handling instructions are provided by the manufacturer to ensure device integrity prior to use.
Other devices from Suzhou Endophix Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What are the Javelot PK-S suture anchors used for in orthopedic surgery?
The Javelot PK-S suture anchors are designed for soft tissue reattachment to bone, commonly used in procedures like Bankart lesion repair and SLAP lesion fixation in the shoulder. They provide a secure fixation point for tendons or ligaments, ensuring stability during healing while gradually resorbing as the tissue integrates with the bone.
Are the Javelot PK-S suture anchors knotless, and what does that mean for surgeons?
Yes, the Javelot PK-S suture anchors are available in knotless variants, which means surgeons do not need to tie manual knots during implantation. This simplifies the surgical process, reduces time in the operating room, and helps maintain stability without relying on knot security.
How are the Javelot PK-S suture anchors supplied, and what are the sterility and usage guidelines?
The Javelot PK-S suture anchors are supplied sterile and intended for single-use only. They must be handled using sterile technique to maintain integrity and prevent contamination. Each anchor is designed for one-time use in a surgical procedure to ensure patient safety and compliance with medical standards.
Are these suture anchors bioabsorbable, and how do they integrate with bone over time?
Yes, the Javelot PK-S suture anchors are bioabsorbable, meaning they gradually resorb as the soft tissue heals and integrates with the bone. This provides temporary fixation while minimizing long-term implant presence, reducing the risk of irritation or complications.
What safety considerations should clinicians be aware of when using these suture anchors?
Clinicians should note that the Javelot PK-S suture anchors are not MRI-safe, so patients must avoid MRI scans post-surgery unless explicitly cleared by the manufacturer. Additionally, proper storage and handling instructions must be followed to preserve device integrity before use, ensuring sterility and functionality during surgery.