← Product Code [HRY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY) · K960617 # ADVANCE TIBIAL COMPONENT (K960617) _Wrightmedicaltechnologyinc · HRY · May 8, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K960617 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [HRY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY.md) - **Decision Date:** May 8, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3530 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ADVANCE™ Tibial Component is intended for tricompartmental or bicompartmental replacement of the knee for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; 5) treatment of fractures that are unmanageable using other techniques. ## Device Story ADVANCE™ Tibial Component; modular two-piece knee replacement system; metal tibial base (cobalt chrome) and plastic insert (UHMWPE). Used in total knee arthroplasty; requires bone cement fixation. Implanted by orthopedic surgeons in hospital setting. Device replaces damaged joint surfaces; restores knee function; reduces pain. Stability provided by femoral-tibial constraint design; locking mechanism secures insert to base. Benefits patient via improved mobility and pain relief. ## Clinical Evidence Bench testing only. Fatigue testing simulated in vivo loading; femoral-tibial contact area testing showed higher conformity than published predicate data; locking detail integrity compared to market systems; femoral-tibial constraint testing (anterior, posterior, medial, lateral shear, and rotation) confirmed stability; UHMWPE material properties verified. ## Technological Characteristics Modular two-piece design; cobalt chrome alloy tibial base; ultra high molecular weight polyethylene (UHMWPE) insert. Cemented fixation. Mechanical stability via femoral-tibial constraint design. ## Regulatory Identification A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Insall/Burstein Modular Total Knee System ## 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} K960617 ![img-0.jpeg](img-0.jpeg) # WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 Contact Person: Judy English Date Prepared: February 12, 1996 # 510(k) Summary of Safety and Effectiveness Trade Name: ADVANCE™ Tibial Component Common Name: Metal-backed Tibial Component Product Classification: II Predicate Device: Insall/Burstein Modular Total Knee System This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. # Description/Intended Use The ADVANCE™ Tibial Component is part of the ADVANCE™ Total Knee System, a total knee replacement system consisting of femoral, tibial, and patellar components. The ADVANCE™ Tibial Component is a modular two-piece component consisting of a metal tibial base and a plastic insert. The ADVANCE™ Tibial Component is intended to be used only with bone cement. The ADVANCE™ Tibial Component is intended for tricompartmental or bicompartmental replacement of the knee for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; 5) treatment of fractures that are unmanageable using other techniques. # Materials The metallic tibial base component is manufactured from cobalt chrome alloy. The tibial insert components are manufactured from ultra high molecular weight polyethylene. # Testing Summary - Submitted fatigue testing demonstrates that the ADVANCE™ Tibial Base Component was able to withstand test loading designed to simulate in vivo loading. - Submitted femoral-tibial contact area testing demonstrates that the ADVANCE™ Tibial Component is more conforming (higher contact area) than independently published data for the predicate device. - Submitted locking detail testing demonstrates that the ADVANCE™ Tibial Component lock detail integrity is comparable to other posterior stabilized knee systems available on the market. - Submitted femoral-tibial constraint testing (anterior shear, posterior shear, medial shear, lateral shear, and rotation) demonstrates that the ADVANCE™ Tibial Component is expected to remain stable and resist displacement when subjected to appropriate physiological loads. - Submitted ultra high molecular weight polyethylene (UHMWPE) properties demonstrate that the ADVANCE™ tibial insert polyethylene components should perform adequately. 000279 285 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K960617](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRY/K960617) **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