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HyProCure II Sinus Tarsi Stent Size 11
FDA UDIClass II (US FDA UDI)
by Gramedica
Identity
- Trade Name
- HyProCure II Sinus Tarsi Stent Size 11 FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Device Name
- HyProCure II Sinus Tarsi Implant Size 11. Indications: HyProCure II (HYP II and HYP IIs) 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-11 FDA UDI
- Description
- HyProCure II Sinus Tarsi Implant Size 11. Indications: HyProCure II (HYP II and HYP IIs) 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-11 FDA UDI
- Primary DI / UDI-DI
- M621HYPII110 FDA UDI
- 510(k) Number
- K142534 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Subtalar implant, non-bioabsorbable 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
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: Subtalar implant, non-bioabsorbable
HyProCure II Sinus Tarsi Stent Size 11 by Gramedica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subtalar implant, non-bioabsorbable.
- HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC. · Class II
- HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC. · Class II
- Subtalar MBA Implant System — Smith & Nephew, Inc. · Class II
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC · Class II
- HORIZON TITANIUM SUBTALAR 12MM — BIOPRO, INC. · Class II
- HORIZON TITANIUM SUBTALAR 6MM — BIOPRO, INC. · Class II
- bioBLOCK® Subtalar Implant System — Ascension Orthopedics, Inc. · Class II
- HORIZON SUBTALAR GEN 2 6MM — BIOPRO, INC. · Class II
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 12 — Gramedica
- HyProCure II Trial Sizer 06 — Gramedica
- HyProCure II Trial Sizer 07 — 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 5f1784b7-0e78-4f77-9edc-f4b81107bd02 37 fields · synced May 30, 2026