Class Class II
Restrata Soft Tissue Reinforcement (STR) (K251224)
Description
Restrata Soft Tissue Reinforcement (STR) by Acera Surgical, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251224
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeOXF
Regulation Number878.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251224
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. Restrata Soft Tissue Reinforcement (STR) (K251224) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 |
| K172603 | Cerafix Dura Substitute | Acera Surgical, Inc. | 2017 |
| K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 |
Trace the full predicate network for K251224
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.