Class Class II
Resolve Modular Revision Hip Stem (K242315)
Description
Resolve Modular Revision Hip Stem by United Orthopedic Corporation, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242315
Clearance Date2025-05-01
Clearance TypeTraditional
Product CodeMEH
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242315
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. Resolve Modular Revision Hip Stem (K242315) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213129 | Restoration Modular 115mm Conical Distal Stem | Howmedica Osteonics Corp., Dba Stry... | 2021 |
| K172251 | UTS Stem | United Orthopedic Corporation | 2017 |
| K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | Biomet, Inc. | 2009 |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | 2005 |
| K051363 | RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | 2005 |
| K022549 | RESTORATION MODULAR SYSTEM | Howmedica Osteonics Corp. | 2002 |
Trace the full predicate network for K242315
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.