Identity
- Trade Name
- HyProCure Instrument Set FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizers (05mm thru 10mm), one Driver and three Guide Wires. For use with the HyProCure Sinus Tarsi Implant system. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion. FDA UDI
- Model / Reference
- HYP-INS-TRAY FDA UDI
- Description
- HyProCure (reusable) Instrument Set. The instrument set contains six Trial Sizers (05mm thru 10mm), one Driver and three Guide Wires. For use with the HyProCure Sinus Tarsi Implant system. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion. FDA UDI
Identifiers
- Catalog Number
- HYP-INS-TRAY FDA UDI
- Primary DI / UDI-DI
- M621HYPINSTRAY0 FDA UDI
- 510(k) Number
- K042030 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
HyProCure Instrument Set by Gramedica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042030 also covers:
- Guide Wire — Gramedica
- HyProCure Driver — Gramedica
- HyProCure Size 05 — Gramedica
- HyProCure Size 06 — Gramedica
- HyProCure Size 07 — Gramedica
- HyProCure Size 08 — Gramedica
- HyProCure Size 09 — Gramedica
- HyProCure Size 10 — Gramedica
- HyProCure Sizer 05 — Gramedica
- HyProCure Sizer 06 — Gramedica
- HyProCure Sizer 07 — Gramedica
- HyProCure Sizer 08 — 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 1b9d26d9-6211-44a4-98cb-e516bae02264 36 fields · synced May 31, 2026