← Product Code [KWY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY) · K960643 # ADVANTAGE MAPF HIP FEMORAL COMPONENT (K960643) _Biomet, Inc. · KWY · Dec 16, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K960643 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [KWY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY.md) - **Decision Date:** Dec 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3390 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Single use, cemented or press-fit hip replacement component for use in patients requiring joint replacement due to trauma, disease or failed previous hip replacement surgery. ## Device Story Advantage MAPF Hip Femoral Component; cobalt alloy (Co-Cr-Mo) femoral stem; straight design; I-beam distal geometry for strength/flexibility; lateral fin for rotational stability; duckbill collar to prevent subsidence. Used in hip replacement surgery; typically for older, low-demand patients; often paired with bipolar or endoprosthetic heads. Articulates with commercially available acetabular components; no joint linkage. Surgeon implants via rasping and seating; straight lateral edge avoids proximal lateral femoral gaps. Benefits include inventory reduction via non-anatomic/non-curved design; 6 size options for patient matching. ## Clinical Evidence No clinical data provided. Safety and effectiveness are based on design equivalence to existing marketed hip replacement components. ## Technological Characteristics Material: Cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. Design: Straight femoral stem, 160mm length, 32mm neck length, 6 sizes. Features: I-beam distal geometry, lateral fin, duckbill collar. Application: Cemented or press-fit. Sterilization: Not specified. ## Regulatory Identification A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction. ## Predicate Devices - Moore Type Stem (Meditac) - APF Moore-Type Femoral Stem (3M) - Advantage MAPF Hip System (Kirschner) - Ranawat/Burstein Hip System (Biomet, Inc) ## 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} 12/10/96 10:15 219 372 1790 BIOMET PURCHSIN 002 # BIOMET DEC 16 1996 K960643 Corporate Headquarters Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Shipping Address: Airport Industrial Park Warsaw, IN 46580 (219) 267-6639 Office (219) 267 8137 FAX ## Summary of Safety and Effectiveness **Sponsor:** Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578 **Device:** Advantage® MAPF® Hip Femoral Component **Classification Name:** Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented (KWY) **Indications for Use:** Single use, cemented or press-fit hip replacement component for use in patients requiring joint replacement due to trauma, disease or failed previous hip replacement surgery. **Device Description:** The Advantage MAPF Femoral Component is a cobalt alloy (Co-Cr-Mo) femoral stem which is designed to articulate with any commercially available acetabular component. It has no linkage across the joint. The MAPF devices are straight, as apposed to anatomic or curved in design. This eliminates the need for left and right configurations thus reducing the cost of inventory to the hospital. The I-beam distal geometry increases the strength and flexibility of the device. The lateral edge of the device is straight which enables the surgeon to rasp and seat the prosthesis, without creating a gap in the proximal lateral aspect of the femur. A lateral fin provides rotational stability. The duckbill type collar prevents subsidence. Available in 6 sizes (diameters) for easier patient matching, all sizes are 160mm in length with a neck length of 32mm. Because this device is usually used in the older, low demand patient, it would most often be used in conjunction with a bipolar or endoprosthetic head. **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 the bone cement | Blood vessel damage | Bone fracture | | --- | --- | --- | | Deformity of the joint | Soft tissue imbalance | Infection | | Cardiovascular disorders | Delayed wound healing | Hematoma | | Fracture of the cement | Metal sensitivity | Dislocation | | Implant loosening/migration | Fracture of the components | Excessive wear | | Breakdown of the porous surface | Tissue growth failure | Nerve damage | **Substantial Equivalence:** In function and overall design, the Advantage MAPF Femoral Components are equivalent to almost all hip components on the market. These stems include: - Moore Type Stem (Meditac) - APF Moore-Type Femoral Stem (3M) - Advantage MAPF Hip System (Kirschner) - Ranawat/Burstein Hip System (Biomet, Inc) --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K960643](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K960643) **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