← Product Code [LPH](/productcode/LPH) · K955563 # FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS (K955563) _Encore Orthopedics, Inc. · LPH · Aug 9, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/device/K955563 ## Device Facts - **Applicant:** Encore Orthopedics, Inc. - **Product Code:** [LPH](/productcode/LPH.md) - **Decision Date:** Aug 9, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. ## Device Story Biolox ceramic femoral head component; used in conjunction with Foundation™ Forged, Textured, and Porous hip stems; intended for total hip arthroplasty; implanted by orthopedic surgeons in hospital setting; replaces natural femoral head/neck damaged by arthritis, necrosis, or fracture; provides articulating surface for hip joint; restores joint function and mobility. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and material characteristics. ## Technological Characteristics Material: Biolox ceramic; component: femoral head; intended for use with Foundation™ hip stems; semi-constrained cemented prosthesis. ## Regulatory Identification A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement. ## Predicate Devices - Biolox heads used with SL-PLUS and SLR-PLUS Stems ([K930963](/device/K930963.md)) ## Reference Devices - Foundation™ Forged Stems ([K952191](/device/K952191.md)) - Foundation™ Textured Stems ([K935263](/device/K935263.md)) - Foundation™ Porous Stems ([K952297](/device/K952297.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K955563 # Summary of Safety and Effectiveness Encore Orthopedics™, Inc. 8900 Shoal Creek Bldg. 300 Austin, TX 78757 512-795-8696 Ashley M. Bock AUG - 9 1996 **Trade Name:** Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems **Common Name:** Ceramic femoral head **Classification Name:** Hip joint metal/ceramic/polymer semi-constrained cemented prosthesis per 21 CFR 888.3353 **Description:** Biolox ceramic heads for use with Foundation™ Forged, Textured and Porous Stems that were cleared for commercial distribution in K952191, K935263 and K952297, respectively. **Intended Use:** Biolox ceramic heads and Foundation™ Forged, Textured and Porous Stems are intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. **Comparable Features to Predicate Device(s):** Features comparable to predicate devices include the Biolox heads used with SL-PLUS and SLR-PLUS Stems cleared for commercial distribution in K930963. 289 --- **Source:** [https://fda.innolitics.com/device/K955563](https://fda.innolitics.com/device/K955563) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com