# K242237: Jewel Soft Tissue Reinforcement Device (102-6005)

- Pathway: 510(k) (Traditional)
- Applicant: Xiros Limited
- Decided: Jul 15, 2025 after 350 days
- Product code: QUW (Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K931386 (1993). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, Xiros, Ltd. (2022) Summary page 5.

## Indications for use
The Jewel Soft Tissue Reinforcement Device is a single-use device intended for reinforcement of soft tissues that are undergoing reconstruction surgery, utilizing autograft or allograft soft tissue grafts, or are to be repaired by suture or other fixation devices during ligament repair surgery. This includes reinforcement of extra-articular ligaments such as, but not limited to, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, and ulnar collateral ligament. The Jewel Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other extra-articular ligaments. Sutures, or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the reconstruction or repair.

Source page: https://510kreport.com/device/K242237
Methodology: https://510kreport.com/methodology