Class Class
Jewel Soft Tissue Reinforcement Device (102-6005) (K242237)
Description
Jewel Soft Tissue Reinforcement Device (102-6005) by Xiros Limited, an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class
510(k) NumberK242237
Clearance Date2025-07-15
Clearance TypeTraditional
FDA Database
View on FDA DatabasePredicate lineage for K242237
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Jewel Soft Tissue Reinforcement Device (102-6005) (K242237) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 |
Trace the full predicate network for K242237
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.