Identity
- Trade Name
- Encompass Hip Stem FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- STD 8x15mm Stem Cemented FDA UDI
- Model / Reference
- 106-0815 FDA UDI
- Description
- STD 8x15mm Stem Cemented FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409011957 FDA UDI
- 510(k) Number
- K050637 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 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 — 8 Millimeter FDA UDIWidth — 15 Millimeter FDA UDI
Category: Metal-on-polyethylene total hip prosthesis
Encompass Hip Stem by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-on-polyethylene total hip prosthesis.
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- U2 Femoral head, Ø36mm, +0mm — UNITED ORTHOPEDIC CORP. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- "UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP. · Class II
- Conformis Hip System — Conformis, Inc. · Class II
- Initia Total Hip System — Kyocera Corporation · Class II
Cleared under the same submission
K050637 also covers:
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP.
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
- Ortho Development Corp.
Sources (1)
- FDA UDI 2f554a20-434d-4adc-8a44-7b06bb2cde0f 36 fields · synced May 30, 2026