Compress Segmental Femoral Replacement System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K043547 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 Compress Segmental Femoral Replacement System is a semi-constrained, uncemented acetabular component designed for hip replacement surgery. It is intended for use in reconstructing the femoral segment of the hip joint, providing stability and support through its metal construction and uncemented fixation.
This system is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K043547) as a Class III device. It is used in orthopedic settings, adhering to standard surgical protocols for hip arthroplasty, and is available in multiple reference codes as listed in the regulatory records. Storage and handling follow sterile medical device protocols to ensure integrity before surgical use.
Frequently asked questions
What types of hip surgeries is the Compress Segmental Femoral Replacement System designed for, and how does its semi-constrained design benefit patients?
The Compress Segmental Femoral Replacement System is specifically designed for reconstructing the femoral segment of the hip joint during hip arthroplasty procedures. Its semi-constrained, uncemented acetabular component provides stability and support by allowing controlled movement while reducing the risk of dislocation compared to fully constrained implants. This design is particularly useful in cases requiring segmental femoral replacement, where maintaining joint stability is critical for patient mobility and long-term outcomes.
Is the Compress Segmental Femoral Replacement System intended for reuse, or is it meant to be used only once per patient?
The Compress Segmental Femoral Replacement System is supplied as a sterile, single-use orthopedic implant. This ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for surgical applications. Reuse is not recommended or intended, as it could compromise the integrity and safety of the device.
How many different sizes or models are available for the Compress Segmental Femoral Replacement System, and how are they identified?
The system is available in multiple reference codes, as listed in the regulatory records under the OpenFDA database. These codes (e.g., 3020282716, 1047843, etc.) correspond to specific sizes or configurations of the implant. The exact sizing details would typically be referenced in the manufacturer’s surgical technique guide or product documentation, ensuring compatibility with individual patient anatomy during hip replacement procedures.
What storage and handling protocols should be followed to maintain the sterility of the Compress Segmental Femoral Replacement System before surgical use?
The system must be stored and handled according to standard sterile medical device protocols to preserve its integrity. This includes keeping the packaging unopened, sealed, and protected from contamination until immediately before use. The manufacturer’s instructions should be followed for specific storage conditions (e.g., temperature, humidity) to ensure the device remains sterile and functional for its intended single-use application.
What regulatory pathway was followed for FDA clearance of the Compress Segmental Femoral Replacement System, and what does this mean for clinicians?
The Compress Segmental Femoral Replacement System received FDA 510(k) clearance (K043547) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it is as safe and effective as a previously approved, legally marketed device in its class. Clinicians can rely on this clearance as evidence of the system’s regulatory compliance and adherence to orthopedic surgical standards, though they should always follow the manufacturer’s instructions and local protocols for use.
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 | K043547 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K043547 24 fields · synced Sep 18, 2026