Balance Hip System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K050251 FDA 510(k)
- FDA Product Code
- KWA FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3330 FDA 510(k)
- Regulation Number
- 888.3330 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Balance Hip System is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). This device is designed to replace the damaged or diseased femoral head and acetabulum in total hip arthroplasty, providing stability and mobility through a semi-constrained design for uncemented fixation.
The system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use device. It is classified as a Class III medical device under FDA regulations (21 CFR 888.3330) and has received FDA 510(k) clearance under the Traditional pathway. Multiple component variants are listed, including various FEI numbers for regulatory tracking.
Frequently asked questions
What types of patients is the Balance Hip System designed to support in total hip arthroplasty procedures?
The Balance Hip System is designed for patients requiring total hip replacement due to damaged or diseased femoral heads and acetabular components. Its semi-constrained, uncemented acetabular design provides stability and mobility, making it suitable for orthopedic surgical settings where uncemented fixation is preferred.
Is the Balance Hip System intended for reuse or is it a single-use device?
The Balance Hip System is explicitly supplied as a sterile, single-use device. This ensures patient safety and reduces the risk of cross-contamination, aligning with best practices for orthopedic implants.
How many component variants are available in the Balance Hip System, and what regulatory tracking numbers are associated with them?
The Balance Hip System includes multiple component variants, each with distinct FEI numbers for regulatory tracking. Over 50 FEI numbers are listed, such as 3020282716, 3007923096, and 1000116912, ensuring traceability for compliance and inventory management.
What storage conditions should be followed for the Balance Hip System to maintain its sterility?
While specific storage instructions aren’t detailed in the provided data, the device is supplied sterile and single-use. Standard orthopedic implant storage practices—such as protecting from moisture, extreme temperatures, and physical damage—should be followed to preserve sterility until surgical use.
What was the regulatory pathway used for FDA clearance of the Balance Hip System, and when was it approved?
The Balance Hip System received FDA 510(k) clearance under the Traditional pathway, with a decision date of May 27, 2005. The device is classified as Class III under 21 CFR 888.3330, reflecting its critical role in orthopedic surgery.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050251 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K050251 24 fields · synced Sep 18, 2026