← Product Code [JWH](/productcode/JWH) · K952943 # CONSENSUS ALL POLY TIBIA (K952943) _U.S. Medical Products, Inc. · JWH · Apr 1, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K952943 ## Device Facts - **Applicant:** U.S. Medical Products, Inc. - **Product Code:** [JWH](/productcode/JWH.md) - **Decision Date:** Apr 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The Consensus® All Poly Tibia is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. 2. Failed osteotomy or unicompartmental replacements 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. ## Device Story Consensus® All Poly Tibia is a symmetric, cruciate-retaining tibial component for total knee arthroplasty; manufactured from ultra-high molecular weight polyethylene (UHMWPE). Device articulates with Consensus® Knee primary femoral components. Inferior surface features dovetail grooves for macro-cement interdigitation with bone. Includes two titanium X-ray markers for post-operative radiographic evaluation. Available in six sizes and five thicknesses (minimum 7.5mm under articulating surface). Intended for use by orthopedic surgeons in clinical settings for patients requiring knee joint replacement. Device provides a stable articulating surface to restore joint function and alleviate pain associated with arthritis or failed prior interventions. ## Clinical Evidence No clinical data provided. Substantial equivalence based on non-clinical performance data and design similarity to predicate devices. ## Technological Characteristics Material: UHMWPE (ASTM F648). Design: Symmetric, cruciate-retaining tibial component. Features: Dovetail grooves on inferior surface for cement interdigitation; two titanium X-ray markers. Dimensions: 6 sizes, 5 thicknesses (min 7.5mm). Sterilization: Provided sterile. ## 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 - Howmedica Duracon All Plastic Tibial component ([K922048](/device/K922048.md)) - Intermedics Orthopedics All-Poly Tibia ([K923443](/device/K923443.md)) - Johnson&Johnson PFC All Plastic Tibia ([K910563](/device/K910563.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} APR - 1 1995 K952943 # ATTACHMENT 8 amended 17 Oct 1995 ## Summary of Safety and Effectiveness ### 510(k) SUMMARY US MEDICAL PRODUCTS, INC. CONSENSUS® KNEE ALL POLY TIBIA | US Medical Products, Inc. 12201 Technology Boulevard Suite 100 Austin, Texas 78727 | William N. Thompson, Director Quality Assurance and Regulatory Affairs Voice (512) 257-4835 Fax (512) 257-8300 Date of Preparation 17 Oct 1995 | | --- | --- | **Trade Name:** Consensus® All Poly Tibia **Common Name:** All Poly (UHMWPE) tibial baseplate knee prosthesis **Classification Name:** Prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer, under classification 21CFR888.3560. **Substantial Equivalence:** equivalent All poly tibia components are as follows: | Howmedica Duracon All Plastic Tibial component K922048 | SE Sep 8, 1992 | | --- | --- | | Intermedics Orthopedics All-Poly Tibia K923443 | SE 3-31-93 | | Johnson&Johnson PFC All Plastic Tibia K910563 | SE 5-23-91 | **Device Description:** The Consensus® Knee All Poly Tibia component is manufactured from ultra-high molecular weight polyethylene (ASTM F648). It is a symmetric cruciate-retaining tibial component and is designed to articulate with the Consensus® Knee primary femoral component. Therefore, it has articulating surface geometry similar to the Consensus® Knee congruent tibial insert component. The inferior surface of each component employs dovetail grooves for macro-cement interdigitation between the implant and the bone. Each component has two titanium X-Ray markers for post-operative evaluation: one placed vertically in the distal end of the stem, and one placed horizontally in the central anterior aspect of the component. The design is available in six sizes and each size is available in five thicknesses. The minimum thickness of polyethylene under the articulating surface is 7.5mm for all sizes. The Consensus® All Poly Tibia will be provided sterile. {1} The Consensus® All Poly Tibia is designed for use with the following Consensus® Total Knee System components: - Consensus® Nonporous CoCr Femoral component - Consensus® Porous CoCr Femoral Component - Consensus® Patellar component, All Polyethylene - Consensus® Patellar component, Titanium/Polyethylene **Intended Use:** The Consensus® All Poly Tibia is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. 2. Failed osteotomy or unicompartmental replacements 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. **Summary of Technological Characteristics:** The Consensus® All Poly Tibia is a symmetric UHMWPE cruciate-retaining tibial component designed to articulate with the Consensus® Knee primary femoral component. The inferior surface employs dovetail grooves for macro cement interdigitation. Each component has two titanium X-Ray markers, and is available in six sizes, each in five thicknesses, minimum 7.5mm articulating surface thickness. **Performance Data:** The device performs with substantial equivalence to predicate devices. **Clinical Data:** None Required **Conclusions from Non-clinical and Clinical Data:** The Consensus® All Poly Tibia is substantially equivalent to predicate devices. **Other Necessary Information:** None Required --- **Source:** [https://fda-staging.innolitics.com/device/K952943](https://fda-staging.innolitics.com/device/K952943) **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. 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