Identity
- Trade Name
- B-P TOTAL HIP SYSTEM FDA UDI
- Generic Name
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- B-P HIP ACETABULAR BEARING - 32 MM I.D. X 50 MM O.D. FDA UDI
- Model / Reference
- 01-02-3250 FDA UDI
- Description
- B-P HIP ACETABULAR BEARING - 32 MM I.D. X 50 MM O.D. FDA UDI
Identifiers
- Catalog Number
- 01-02-3250 FDA UDI
- Primary DI / UDI-DI
- 00814193022783 FDA UDI
- 510(k) Number
- K963101 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDI
- GMDN Term
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 50 Millimeter FDA UDILumen/Inner Diameter — 32 Millimeter FDA UDI
Category: Ceramic-on-polyethylene total hip prosthesis
B-P Total Hip System by Endotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ceramic-on-polyethylene total hip prosthesis.
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP. · Class II
- Conformis Hip System — Conformis, Inc. · Class II
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
Cleared under the same submission
K963101 also covers:
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, 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
- Endotec, Inc.
Sources (1)
- FDA UDI 59ef60ca-b3b3-4399-946b-23986e4d3405 37 fields · synced May 30, 2026