Identity
- Trade Name
- Genius Total Knee System FDA UDI
- Generic Name
- Uncoated knee femur prosthesis, metallic FDA UDI
- Model / Reference
- 121-07-1160 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215021504 FDA UDI
- 510(k) Number
- K170613 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Uncoated knee femur prosthesis, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Uncoated knee femur prosthesis, metallic
Genius Total Knee System by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee femur prosthesis, metallic.
- SIGMA — DEPUY (IRELAND) · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- LEGION — Smith & Nephew, Inc. · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- Orthopedic Salvage System (OSS™) — Biomet Orthopedics, Inc. · Class II
- GMK Sphere Revision System — Medacta International · Class II
- ACS® — implantcast GmbH · Class II
- Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · Class II
Cleared under the same submission
K170613 also covers:
- Crescendo Femoral Component Cemented - CR Size 2L — Amplitude
- Crescendo Femoral Component Cemented - PS Size 2L — Amplitude
- Crescendo Femoral Component Cemented - PS Size 5R — Amplitude
- Crescendo Meniscal Insert CR Standard 11mm Size 0 — Amplitude
- Crescendo Meniscal Insert CR Standard 12mm Size 2 — Amplitude
- Crescendo Meniscal Insert CR Standard 12mm Size 5 — Amplitude
- Crescendo Meniscal Insert CR Standard 13mm Size 3 — Amplitude
- Crescendo Meniscal Insert CR Standard 15mm Size 5 — Amplitude
- Crescendo Meniscal Insert CR Standard 17mm Size 3 — Amplitude
- Crescendo Meniscal Insert CR Ultracongruent 12mm Size 2 — Amplitude
- Crescendo Meniscal Insert CR Ultracongruent 12mm Size 5 — Amplitude
- Crescendo Meniscal Insert CR Ultracongruent 15mm Size 3 — Amplitude
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
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI b4554661-7a25-406d-a331-37e6f993979e 33 fields · synced Jun 1, 2026