Hitch LactoSorb Suture Anchor
510(k) K061657
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061657 | Date25 Jul 2006 | 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- Withdrawn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
- JDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Hitch LactoSorb Suture Anchor is a resorbable implant for soft tissue reattachment. It consists of L-Lactide/Glycolide material preloaded with #2 polyethylene surgical sutures. The device is used in orthopedic procedures to secure soft tissue to bone.
The surgeon inserts the anchor into bone via a pre-drilled hole or by screwing into a tapped pre-drilled hole. It is available in various sizes and is intended for use in shoulder, wrist/hand, elbow, and knee procedures. The device has FDA 510(k) clearance with product code JDR.
Other devices from Arthrotek, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the Hitch LactoSorb Suture Anchor used for?
The Hitch LactoSorb Suture Anchor is used to secure soft tissue to bone in orthopedic procedures such as shoulder, wrist/hand, elbow, and knee surgeries, providing resorbable fixation for tissue reattachment.
How is the Hitch LactoSorb Suture Anchor supplied and implanted?
The device is supplied preloaded with #2 polyethylene surgical sutures and is implanted by inserting it into a pre-drilled bone hole or by screwing it into a tapped pre-drilled hole during surgery.
Is the Hitch LactoSorb Suture Anchor designed for single use or reuse?
The Hitch LactoSorb Suture Anchor is a single-use implant intended for one-time implantation; it is not designed for cleaning, sterilization, or reuse after initial use.
What sizes and models are available for the Hitch LactoSorb Suture Anchor?
The device is available in various sizes to accommodate different anatomical sites and surgical needs in shoulder, wrist/hand, elbow, and knee procedures, though specific size dimensions are not detailed in the provided data.
How should the Hitch LactoSorb Suture Anchor be stored before use?
While specific storage conditions are not stated in the device data, as a sterile, resorbable implant, it should be stored in its original packaging under standard medical device conditions to maintain sterility and material integrity until use.