Providence Cup System
FDA 510(k)Class II (US FDA 510(k))
by Biopro, Inc.
Identifiers
- 510(k) Number
- K990821 FDA 510(k)
- FDA Product Code
- JDI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3350 FDA 510(k)
- Regulation Number
- 888.3350 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Providence Cup System is a semi-constrained hip prosthesis designed for cemented fixation in total hip arthroplasty. It consists of a metal acetabular cup paired with a polymer liner, providing structural support and articulation within the hip joint.
This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under product code JDI and has received FDA 510(k) clearance (K990821) as a Class II medical device under Special Controls. Storage and handling must comply with standard orthopedic implant protocols to maintain sterility and integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K990821 - PROVIDENCE CUP SYSTEM | FDA 510(k) | Biopro, Inc., PROVIDENCE CUP SYSTEM (K990821) — FDA 510 (k) | Innolitics, World-class health care with human connection | Providence
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990821 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA 510(k) K990821 24 fields · synced Sep 19, 2026