Resolve Modular Revision Hip Stem
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Resolve Modular Revision Stem EUDAMEDResolve Modular Revision Hip Stem FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- Resolve interlocking stem trial, Ø17×220mm EUDAMEDFDA UDI
- Model / Reference
- 1112-8217 EUDAMEDFDA UDI
- Description
- Resolve interlocking stem trial, Ø17×220mm FDA UDI
Identifiers
- Catalog Number
- 1112-8217 FDA UDI
- Primary DI / UDI-DI
- 04719886901399 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719886901399 EUDAMED
- 510(k) Number
- K242315 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDIMEH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Femoral stem prosthesis trial
Resolve Modular Revision Hip Stem by United Orthopedic Corp. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Femoral stem prosthesis trial.
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
- MALLORY/HEAD MODULAR — Biomet Orthopedics, Inc. · Class I
- EXACT REVERSE FP FULL TOOTH RASP — Zimmer, Inc. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- ZMR® — Zimmer, Inc. · Class II
Cleared under the same submission
K242315 also covers:
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
- Resolve Modular Revision Hip Stem — UNITED ORTHOPEDIC CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI 703aa85f-8273-4a4f-a463-b2906190c6f5 36 fields · synced Oct 9, 2026
- EUDAMED 28ad9047-2bb0-4461-8870-8beacd4857d3 61 fields · synced Oct 9, 2026