Class Class II
Total Wrist Arthroplasty System (TWA) (K243381)
Description
Total Wrist Arthroplasty System (TWA) by Skeletal Dynamics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243381
Clearance Date2024-11-01
Clearance TypeSpecial
Product CodeJWJ
Regulation Number888.3800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243381
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. Total Wrist Arthroplasty System (TWA) (K243381) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | 2024 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026 |
Trace the full predicate network for K243381
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.