← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K961482 # DURACON INSET PATELLA WITH CENTRAL PEG (K961482) _Howmedica Corp. · JWH · Jul 5, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K961482 ## Device Facts - **Applicant:** Howmedica Corp. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Jul 5, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella. ## Device Story All-polyethylene concentric dome patella; used as component in total knee system with Duracon and P.C.A. MTK II femoral/tibial components. Implanted via bone cement. Replaces articular surface of patella in primary or revision surgery. Surgeon-operated in clinical setting. Benefits patient by restoring patellofemoral joint function. ## Clinical Evidence Bench testing only. Comparative patello-femoral contact area and shear testing performed against legally marketed predicate device. ## Technological Characteristics Material: Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F 648. Design: Concentric dome patella with central peg. Fixation: Bone cement. Energy source: None (mechanical implant). ## 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 - Duracon® Recessed Patella (Howmedica) - Duracon® All-Poly Patella (Howmedica) - Genesis Biconvex Patella (Smith & Nephew Richards) - Omnifit All-Polyethylene Patella (Osteonics) - Miller-Galante II All-Polyethylene Patella (Zimmer) - Kinematic® II All-Polyethylene Patella (Howmedica) ## 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} APPENDIX H JUL - 5 1996 510(k) SUMMARY X961482 Device: Duracon® Inset Patella with Central Peg Common Name: Concentric Dome Patella Classification Name and Reference: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR 888.3560 Proposed Regulatory Class: Class II Device Product Code: JWH (OR) This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella. This patella component is similar in intended use, material, design and operational principles to other legally marketed devices. These devices include: 1) Duracon® Recessed Patella (Howmedica); 2) Duracon® All-Poly Patella (Howmedica); 3) Genesis Biconvex Patella (Smith & Nephew Richards); 4) Omnifit All-Polyethylene Patella (Osteonics); 5) Miller-Galante II All-Polyethylene Patella (Zimmer) and 6) Kinematic® II All-Polyethylene Patella (Howmedica). All of the devices are fabricated from Ultra-High Molecular Weight Polyethylene which conforms to ASTM Specification F 648. All of the named components have the same intended use. All of the named devices are implanted using bone cement. Patello-femoral contact area and shear testing were presented, with a comparison to a legally marketed device. For information, contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7431 - Phone (201) 507-6870 - Fax --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K961482](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K961482) **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