← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K963796 # KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS (K963796) _Howmedica Corp. · JWH · Dec 9, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K963796 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Dec 9, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are intended to be used with Kinemax® and Kinemax® Plus tibial and patellar components as a total knee system. These components are intended to be used in total knee replacement procedures indicated due to inflammatory or non-inflammatory joint disease, failed previous prosthesis, or trauma. Specifically, this femoral component is intended to be used in situations where a stemmed component is desired to provide additional stability. This femoral component allows the surgeon to use (as an option) femoral spacers to augment bone loss on the distal or distal/posterior surfaces of the femur. These components are intended to be implanted using bone cement. ## Device Story Modular femoral component and spacers for total knee arthroplasty; used with Kinemax/Kinemax Plus tibial and patellar components. Provides stemmed stability; allows distal/posterior bone loss augmentation via spacers. Implanted via bone cement. Used in surgical settings by orthopedic surgeons. Output is physical structural support for knee joint; aids clinical decision-making by restoring joint function and stability in patients with degenerative or traumatic joint failure. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Modular femoral component and spacers; cemented fixation. Materials consistent with existing Kinemax/Duracon systems. Designed for use with Kinemax/Kinemax Plus tibial and patellar components. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Kinemax® Plus Stabilizer Femoral Component ([K910500](/device/K910500.md)) - Duracon® Stemmed Stabilizer Femoral Component ([K932070](/device/K932070.md)) - Duracon® Femoral Spacers ([K920034](/device/K920034.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} K963796 DEC 9 1996 510(k) Summary Device: Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers Common Name: Modular Femoral Component and Femoral Spacers Classification Name and Reference: 21 CFR 888.3560 Knee Joint patellofemorotibial semi-constrained cemented prosthesis Proposed Regulatory Class: Class II Device Product Code: JWH OR(87) The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are intended to be used with Kinemax® and Kinemax® Plus tibial and patellar components as a total knee system. These components are intended to be used in total knee replacement procedures indicated due to inflammatory or non-inflammatory joint disease, failed previous prosthesis, or trauma. Specifically, this femoral component is intended to be used in situations where a stemmed component is desired to provide additional stability. This femoral component allows the surgeon to use (as an option) femoral spacers to augment bone loss on the distal or distal/posterior surfaces of the femur. These components are intended to be implanted using bone cement. The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are substantially equivalent to several other legally marketed devices. Examples of these are listed below: 1. Kinemax® Plus Stabilizer Femoral Component (Howmedica - K910500) 2. Duracon® Stemmed Stabilizer Femoral Component (Howmedica - K932070) 3. Duracon® Femoral Spacers (Howmedica - K920034) For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7431 Fax: (201) 507-6870 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K963796](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K963796) **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