KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS
Device Facts
| Record ID | K963796 |
|---|---|
| Device Name | KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS |
| Applicant | Howmedica Corp. |
| Product Code | JWH · Orthopedic |
| Decision Date | Dec 9, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3560 |
| Device Class | Class 2 |
| 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.
Indications for Use
Indicated for patients requiring total knee replacement due to inflammatory or non-inflammatory joint disease, failed previous prosthesis, or trauma. Specifically for cases requiring stemmed components for additional stability or femoral spacers for bone loss augmentation.
Regulatory Classification
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)
- Duracon® Stemmed Stabilizer Femoral Component (K932070)
- Duracon® Femoral Spacers (K920034)
Related Devices
- K973164 — HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS · Howmedica Corp. · Nov 20, 1997
- K964951 — KINEMAX PLUS TIBIAL SPACERS · Howmedica Corp. · Feb 24, 1997
- K094017 — TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 · Omni Life Science, Inc. · Mar 5, 2010
- K140302 — OPTETRAK LOGIC POROUS FEMORAL COMPONENTS · Exactech, Inc. · Jul 30, 2014
- K021740 — TOTAL KNEE CEMENTED, SEMI-CONSTRAINED · Dj Orthopedics, LLC · Sep 23, 2002
