Identity
- Trade Name
- STRATUS Stem FDA UDI
- Generic Name
- Coated femoral stem prosthesis, modular FDA UDI
- Model / Reference
- 1-01-18-1801 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701089521413 FDA UDI
- 510(k) Number
- K121297 FDA UDI
- FDA Product Code
- MEH FDA UDI
- GMDN Term
- Coated femoral stem prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coated femoral stem prosthesis, modular
STRATUS Stem by Amplitude — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated femoral stem prosthesis, modular.
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
- STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
- MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Alteon — Exactech, Inc. · Class II
- ANTHOLOGY — Smith & Nephew, Inc. · Class III
- TheRay Collared and Collarless Femoral Stem — Nextstep Arthropedix · Class II
Cleared under the same submission
K121297 also covers:
- Nifty Fifty VENTO Cup — Amplitude
- SIGNATURE Head - BIOLOX Delta — Amplitude
- SIROCCO Stem — Amplitude
- SIROCCO Stem — Amplitude
- SIROCCO Stem — Amplitude
- VENTO Cup — Amplitude
- VENTO Cup — Amplitude
- VENTO XLPE Liner — Amplitude
- VENTO XLPE Liner — Amplitude
- OrthoMedFlex — ORTHOMEDFLEX LLC
- Paxeon Aria — PAXEON RECONSTRUCTION LLC
- Paxeon Aria — PAXEON RECONSTRUCTION LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Amplitude
Sources (1)
- FDA UDI d153c036-9564-4c38-a3a4-800bf0f12b9b 34 fields · synced May 30, 2026