# K251310: OTS 25-L (100-5)

- Pathway: 510(k) (Traditional)
- Applicant: Ots Medical, Ltd.
- Decided: Jul 22, 2025 after 85 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911837 (1991). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241234: OTS 25-L (100-5), Ots Medical, Ltd. (2025) Summary page 6.
- K151068: SureLock W Suture Anchor, Cayenne Medical, Inc. (2015) Summary page 5.

## Indications for use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OTS 25-L All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, both may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue.

Source page: https://510kreport.com/device/K251310
Methodology: https://510kreport.com/methodology