Identity
- Trade Name
- HyProCure II Trial Sizer 12 FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- HyProCure II Trial Sizer 12 instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. FDA UDI
- Model / Reference
- HYP II-TS-12 FDA UDI
- Description
- HyProCure II Trial Sizer 12 instrument. For use with the HyProCure II Sinus Tarsi Implant System. Indications: The HyProCure II (HYP II and HYP IIs) Implant is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion. FDA UDI
Identifiers
- Catalog Number
- HYP II-TS-12 FDA UDI
- Primary DI / UDI-DI
- M621HYPIITS120 FDA UDI
- 510(k) Number
- K142534 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 18.20 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
HyProCure II Trial Sizer 12 by Gramedica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142534 also covers:
- Guide Wire — Gramedica
- HyProCure II Driver — Gramedica
- HyProCure II Instrument Tray-Set — Gramedica
- HyProCure II Positioning Sleeve — Gramedica
- HyProCure II Sinus Tarsi Stent Size 06 — Gramedica
- HyProCure II Sinus Tarsi Stent Size 07 — Gramedica
- HyProCure II Sinus Tarsi Stent Size 08 — Gramedica
- HyProCure II Sinus Tarsi Stent Size 09 — Gramedica
- HyProCure II Sinus Tarsi Stent Size 10 — Gramedica
- HyProCure II Sinus Tarsi Stent Size 11 — Gramedica
- HyProCure II Sinus Tarsi Stent Size 12 — Gramedica
- HyProCure II Trial Sizer 06 — Gramedica
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
- Gramedica
Sources (1)
- FDA UDI 200567b5-540e-4bd8-996c-dba1e43f0023 37 fields · synced Jun 1, 2026