KISSLOC Knotless Suture System
510(k) K133835
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133835 | Date3 Jul 2014 | 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- Withdrawn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
- Full name
- Arthrosurface Kissloc Knotless Suture System
- 510(k) Number
- FDA Product Code
- HTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The KISSLOC Knotless Suture System is a non-resorbable bone fixation implant classified as a suture anchor and fixation device (HTN product code). It is designed for realignment and stabilization of skeletal deformities, particularly hallux valgus, by providing secure fixation without the need for traditional knot tying. The system includes a suture plate, an arrow plate, and a UHMWPE (ultra-high-molecular-weight polyethylene) suture assembly to create a stable construct.
The device is used in orthopedic surgical settings for soft tissue and bone fixation, supplied sterile for single-use. It is intended for use by trained surgeons in procedures requiring secure fixation without knots. The system adheres to FDA 510(k) clearance (K133835) under the Orthopedic Advisory Committee and is intended for traditional medical device classification. No additional regulatory status beyond the stated clearance is implied.
Other devices from Arthrosurface, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of orthopedic procedures is the KISSLOC Knotless Suture System specifically designed for?
The KISSLOC Knotless Suture System is designed for realignment and stabilization of skeletal deformities, particularly hallux valgus (a common bunion condition). It provides secure fixation for soft tissue and bone without requiring traditional knot tying, making it ideal for procedures where knotless anchoring improves stability and reduces surgical complexity.
How is the KISSLOC Knotless Suture System supplied, and is it reusable?
The system is supplied sterile and intended for single-use only. Each package contains a suture plate, arrow plate, and UHMWPE suture assembly, ensuring compliance with sterile surgical standards. Reuse is not recommended or supported by the manufacturer.
What materials are used in the KISSLOC Knotless Suture System, and how does this affect its stability?
The system includes a suture plate and arrow plate (likely metallic) paired with an ultra-high-molecular-weight polyethylene (UHMWPE) suture assembly. UHMWPE is known for its durability and resistance to wear, which enhances the stability of the construct during bone fixation, particularly in procedures like hallux valgus correction.
What storage requirements should I follow for the KISSLOC Knotless Suture System?
While specific storage conditions aren’t detailed in the provided data, the system is sterile at time of use, so it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for any manufacturer-recommended storage instructions.
How does the KISSLOC Knotless Suture System differ from traditional suture anchors in terms of use?
Unlike traditional suture anchors that require knot tying for fixation, the KISSLOC system uses a knotless design with a pre-assembled UHMWPE suture and plates (suture/arrow plates) to create a stable construct. This eliminates the need for manual knot tying, potentially reducing surgical time and improving consistency in procedures like hallux valgus correction.