Identity
- Trade Name
- Rx Knee AP Symmetrical Augment Size 9 - 4mm Poly FDA UDI
- Generic Name
- Temporary knee prosthesis, non-customized FDA UDI
- Model / Reference
- 121-20-9169 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215110321 FDA UDI
- 510(k) Number
- K240683 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Temporary knee prosthesis, non-customized 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: Temporary knee prosthesis, non-customized
Rx Knee AP Symmetrical Augment Size 9 - 4mm Poly by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary knee prosthesis, non-customized.
- Rx Knee Tibial Cone Augment Size Stackable — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Rx Knee AP Symmetrical Augment Size 4 - 12mm Poly Draft — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Rx Knee Femoral Augment — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Rx Knee Universal Stem — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Rx Knee AP Symmetrical Augment Size 8 - Titanium Wedged 3 DEG Right — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Rx Knee AP Symmetrical Augment Size 4 - 12mm Titanium Draft — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Rx Knee Femoral Augment — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Rx Knee Tibial Stem — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Cleared under the same submission
K240683 also covers:
- Rx Knee AP Symmetrical Augment Size 1 - 12mm Poly Half — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 1 - 12mm Titanium Draft — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 1 - 12mm Titanium Half Draft Left — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 1 - 4mm Poly — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 1 - 4mm Titanium — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 1 - 8mm Poly Half — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 1 - 8mm Poly Half Draft Right — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 1 - Titanium Wedged 3 DEG Right — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 2 - 12mm Poly Half — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 2 - 12mm Titanium Draft — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 2 - 4mm Titanium — SIGNATURE ORTHOPAEDICS PTY LTD
- Rx Knee AP Symmetrical Augment Size 2 - 4mm Titanium Half — SIGNATURE ORTHOPAEDICS PTY LTD
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 805edcb5-e0a1-4ff7-ae46-c70774263aab 33 fields · synced Jun 8, 2026