← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K972967 # OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT (K972967) _Osteonics Corp. · JWH · Jan 16, 1998 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K972967 ## Device Facts - **Applicant:** Osteonics Corp. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Jan 16, 1998 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are intended to articulate with any commercially available Osteonics® Scorpio™ Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral Component, and any commercially available Osteonics® Omnifit® Total Knee Fernoral Component. The subject patellar components are single use devices, intended for cemented application onto the surgically prepared posterior patella. These components replace the patellar articulating surface of the knee joint and simulate the natural function of the knee. ## Device Story Patellar prosthetic components fabricated from UHMWPE; circular dome or recessed button configuration with three fixation pegs on anterior surface; features circular grooves/pockets for cement interdigitation. Used in total knee arthroplasty; implanted by orthopedic surgeons in clinical/OR settings. Device replaces patellar articulating surface; articulates with specific Osteonics femoral components. Cemented fixation required. Benefits include restoration of knee joint function and pain relief for patients with degenerative or post-traumatic joint disease. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Material: Ultra-high molecular weight polyethylene (UHMWPE). Design: Circular dome or recessed button with three fixation pegs; circular grooves/pockets for cement interdigitation. Thickness: 8mm and 10mm. Fixation: Cemented only. Connectivity: 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 - Osteonics® Scorpio™ Total Knee All-Polyethylene Patellar Components - Johnson and Johnson® P.F.C.® Cruciate Sacrificing Patellar Component ## 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}------------------------------------------------ Osteonics" Scorpio™ Total Knee Universal Dome and Recessed Patellar Components K972967 510(k) Premarket Notification 510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS IAN 6 1998 Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components Submission Information Name and Address of the Sponsor of the 510(k) Submission: Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900 Donna S. Wilson Regulatory Affairs Specialist Date Summary Prepared: Device Identification Proprietary Name: Contact Person: August 8. 1997 Osteonics® Scorpio™ Total Knee Universal Dome Patellar Component; Osteonics® Scorpio™ Total Knee Recessed Patellar Component Common Name: Classification Name and Reference: Knee Prosthesis Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis 21 CFR §888.3560 #### Predicate Device Identification The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are substantially equivalent to other legally marketed, Class II, patellar components, including the Osteonics® Scorpio™ Total Knee All-Polyethylene Patellar Components - concentric dome design, and the Johnson and Johnson® P.F.C.® Cruciate Sacrificing Patellar Component. ## Device Description The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are fabricated from ultra-high molecular weight polyethylene (UHMWPE). The articular geometry is designed with a round dome topography. The overall geometry essentially consists of a circular {1}------------------------------------------------ patellar button configuration with three fixation pegs on the anterior surface of the component. The anterior surface of the components also features circular grooves and pockets for cement interdigitation. Each patellar component is available in 8mm and 10mm dome thicknesses. ### Intended Use : The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are intended to articulate with any commercially available Osteonics® Scorpio™ Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral Component, and any commercially available Osteonics® Omnifit® Total Knee Fernoral Component. The subject patellar components are single use devices, intended for cemented application onto the surgically prepared posterior patella. These components replace the patellar articulating surface of the knee joint and simulate the natural function of the knee. # Statement of Technological Comparison The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components share the same materials, intended use, basic surgical techniques, and basic design features of their predicate devices. Applicable performance testing demonstrates that the subject devices perform at least as well as, if not better than, commercially available designs. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 16 1998 Robert A. Koch, J.D. · Director, Regulatory/Legal Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677 K972967 Re: Osteonics® Scorpio™ Total Knee Universal Trade Name: Dome and Recessed Patellar Components Requlatory Class: II Product Code: JWH Dated: November 13, 1997 November 14, 1997 Received: Dear Mr. Koch: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations: - This device may not be labeled or promoted for non-1. cemented use. - All labeling for this device, including package label 2. and labeling included within the package, must- -----------prominently state that the device is intended for cemented use only. - Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation. {3}------------------------------------------------ Page 2 - Robert A. Koch, J.D. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general - {4}------------------------------------------------ information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Cecelia M. Whitten, Ph.D. a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## 510(k) Number (if known): K 91 - 2967 # Device Name: Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components ### Indications For Use: The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are intended to articulate with any commercially available Osteonics® Scorpio™ Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral Component, and any commercially available Osteonics® Omnifit® Total Knee Femoral Component. The subject patellar components are single use devices, intended for cemented application onto the surgically prepared posterior patella. These components replace the patellar articulating surface of the knee joint and simulate the natural function of the indications for the use of the Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components in conjunction with a total knee replacement. in keeping with those of other legally marketed Class II patellar components, are as follows: #### Indications: - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis. - . Post-traumatic loss of knee joint configuration and function. - . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - Revision of previous unsuccessful knee replacement or other procedure. . # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use × (Per 21 CFR 801.109) OR Over-The-Counter Use _ (Division Sign-Off) (Optional Format 1.2.96 (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices 510(k) Number. R972967 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K972967](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K972967) **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