Identity
- Trade Name
- MBA™ Titanium Subtalar Implant System FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Device Name
- The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. FDA UDI
- Model / Reference
- 050109 FDA UDI
- Description
- The MBA titanium subtalar implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. The implants are indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. FDA UDI
Identifiers
- Catalog Number
- 050109 FDA UDI
- Primary DI / UDI-DI
- 10381780065517 FDA UDI
- 510(k) Number
- K960692 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
MBA™ Titanium Subtalar Implant System by Ascension Orthopedics, Inc. — 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
- HyProCure II Sinus Tarsi Stent Size 06 — Gramedica · Class II
- HORIZON TITANIUM SUBTALAR 12MM — BIOPRO, INC. · Class II
- HORIZON TITANIUM SUBTALAR 6MM — BIOPRO, INC. · Class II
- HORIZON SUBTALAR GEN 2 6MM — BIOPRO, INC. · Class II
Cleared under the same submission
K960692 also covers:
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI f207df12-3cac-4a6b-895f-fb2ddee769fe 39 fields · synced May 31, 2026