# K233429: OTS 25 (100-1)

- Pathway: 510(k) (Traditional)
- Applicant: Ots Medical, Ltd.
- Decided: Dec 7, 2023 after 57 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: 12 generations back to K911837 (1991). 81 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133224: Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi Sutures, Conmed Corporation (2014)
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor, Biomet, Inc. (2011)

## Most influential descendants
- K241234: OTS 25-L (100-5) (2025), 1 descendant of its own
- K251310: OTS 25-L (100-5) (2025), 0 descendants of its own

## Indications for use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The OTS 25 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/K233429
Methodology: https://510kreport.com/methodology