← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K960303 # FENNING FEMORAL COMPONENT (K960303) _Biomet, Inc. · LPH · Jun 21, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K960303 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md) - **Decision Date:** Jun 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Biomet's Fenning Femoral Component is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint. ## Device Story Metallic femoral stem for hip arthroplasty; designed for articulation with commercially available acetabular components. Features 30° conical collar with plasma-sprayed porous coating for biological fixation without bone cement; proximal lateral porous coating promotes tissue ingrowth. Stem geometry tapered to match canal contours; grit-blasted mid-section; smooth, fluted distal section with coronal slot to reduce stiffness. Used by orthopedic surgeons in clinical settings. Provides rotational stability and stress transfer to proximal femur via collar wedging. Eliminates need for trochanter resection; straight design avoids left/right configuration. Benefits include stable fixation and reduced distal stiffness. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Metallic femoral stem; plasma-sprayed porous coating; grit-blasted surface (200 microinches); fluted distal section. Dimensions: 9mm-17mm diameters, 145mm-165mm lengths. Straight, non-linked, semi-constrained design. Biological fixation via tissue ingrowth; no bone cement used. ## 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 - PSL Total Hip (BioPro) ([K922500](/device/K922500.md)) - Conical Collar Hip (Kirschner) ([K854046](/device/K854046.md)) - C₂ Osteocap Hip (Kirschner) ([K861450](/device/K861450.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} JUN 21 1986 K96 0303 # SUMMARY OF SAFETY AND EFFECTIVENESS Sponsor: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580 Device: Fenning Femoral Component Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis. Device Description: Biomet's Fenning Femoral Component is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint. The stem has a 30° collar with plasma sprayed porous coating circumferentially on the underside of the collar, including the cone; the porous coating extends to the proximal lateral 1/4 of the stem: 1.5 inches from the top laterally to below the collar medially. Porous coating is to achieve biological fixation to the surrounding bone by tissue, either bone or soft tissue, without the use of bone cement. The porous coating on the underside of a collar and the extended proximal lateral porous coating provide areas of potential tissue ingrowth in crucial regions of cortical bone. The conical collar design provides a larger contact surface for stress transfer to the proximal femur via the collar wedging into the bone. The wedging of the implant into the canal allows the entire collar to sit on cortical bone occluding the proximal canal while providing rotational stability of the stem. There is no lateral collar eliminating the need to resect the greater trochanter. The stem is tapered, following the natural contours of the canal. The stem below the porous coating to the middle portion is "grit blasted" for a roughened surface of 200 microinches. The distal half of the stem is smooth and fluted. The flutes provide additional rotational stability. There is a distal coronal slot to minimizes distal stem stiffness. The device will be available in 5 stem sizes of diameters 9mm to 17mm at 2mm increments with corresponding stem lengths of 145mm to 165mm at 5mm increments. The stem is straight eliminating the need for left and right configurations. 60.3029 {1} Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to: - Reaction to bone cement - Fracture of the components - Cardiovascular disorders - Implant loosening/migration - Soft tissue imbalance - Deformity of the joint - Tissue growth failure - Delayed wound healing - Fracture of the cement - Bone fracture - Hematoma - Blood vessel damage - Nerve damage - Excessive wear - Infection - Dislocation - Metal sensitivity Substantial Equivalence: In function and overall design Biomet's Fenning Femoral Component is equivalent to almost all hip components on the market. These stems include: - PSL Total Hip (BioPro) 510(k) K922500 - Conical Collar Hip (Kirschner) 510(k) K854046 - C₂ Osteocap Hip (Kirschner) 510(k) K861450 000030 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K960303](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K960303) **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