Foundation Forged, Textured & Porous Stems W/Biolox Ceramic Heads
510(k) K955563
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK955563 | Date9 Aug 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LPH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3358
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Overview
AI-generated summary, 1 Oct 2026
This device is a total hip arthroplasty system comprising forged, textured, and porous femoral stems paired with Biolox ceramic femoral heads. It is designed to replace a damaged or diseased natural femoral head and neck, restoring joint articulation and mobility in patients with conditions such as osteoarthritis, avascular necrosis, or fractures. The stems integrate with bone via porous coating, while the Biolox ceramic heads provide a durable, low-friction articulating surface. The combination aims to improve hip function and longevity in total hip replacement procedures.
The system is intended for use in hospital settings by orthopedic surgeons during total hip arthroplasty. It is supplied as a sterile, single-use implant and has received FDA 510K clearance under the traditional review pathway. No additional regulatory markings or MRI safety classifications are specified in the available data. Proper storage and handling per manufacturer instructions are required to maintain sterility and performance. The device is categorized under the Orthopedic advisory committee and assigned product code LPH.
Other devices from Encore Orthopedics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What conditions is this device designed to treat?
This device is specifically designed for total hip arthroplasty to replace a damaged or diseased natural femoral head and neck in patients suffering from conditions such as osteoarthritis, avascular necrosis, or fractures. The system aims to restore joint articulation and mobility by integrating with bone via porous coating and providing a low-friction ceramic articulating surface.
How is this device supplied and intended for use?
The Foundation Forged, Textured & Porous Stems with Biolox Ceramic Heads are supplied as sterile, single-use implants. They are intended for use exclusively in hospital settings by orthopedic surgeons during total hip arthroplasty procedures, ensuring proper surgical conditions for implantation.
Is this device reusable or single-use?
This device is designed for single-use only. Its sterile packaging and intended surgical application in controlled environments ensure patient safety and compliance with medical standards. Reuse is not recommended or supported by the manufacturer.
What materials are used in the femoral heads and stems?
The femoral heads are made from Biolox ceramic, a durable material known for its low-friction properties, while the stems are forged, textured, and porous to enhance bone integration. The combination of these materials aims to improve joint longevity and function in total hip replacements.
How should this device be stored to maintain sterility and performance?
Proper storage and handling per manufacturer instructions are required to maintain sterility and performance. This includes following guidelines for shelf life, environmental conditions, and protective packaging to ensure the device remains uncontaminated and functional until use in surgery.