← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K991461 # OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT (K991461) _Howmedica Osteonics Corp. · JWH · May 17, 1999 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K991461 ## Device Facts - **Applicant:** Howmedica Osteonics Corp. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** May 17, 1999 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The intended use of the modified tibial bearing inserts is identical to that of the unmodified tibial bearing inserts. As with the predicate tibial bearing inserts, the modified tibial bearing inserts are single use devices. They are intended for mating with commercially available Osteonics® Tibial Trays and corresponding posteriorly stabilized femoral and patellar components. The Osteonics® Scorpio™ Posteriorly Stabilized Total Knee Components are intended for cemented fixation. Specific indications for use are as follows: 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. Ligamentous instability requiring implant bearing surface geometries with increased constraint. Absent or non-functioning posterior cruciate ligament. ## Device Story Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert is a modified UHMWPE knee prosthesis component. Modification involves increasing posterior radius from 3 to 6 inches to facilitate deeper flexion angles by resisting femoro-tibial distraction and increasing ligament tension. Device is a single-use implant intended for cemented fixation with existing Osteonics® tibial trays and femoral/patellar components. Used by orthopedic surgeons in clinical/surgical settings for total knee arthroplasty. Output is a physical bearing surface that restores joint function and stability. Benefits include improved range of motion and stability for patients with severe knee pathology. ## Clinical Evidence Bench testing only. Risk analysis and R&D testing performed to demonstrate substantial equivalence to the predicate design. ## Technological Characteristics UHMWPE tibial bearing insert; cemented fixation; posterior radius modified to 6 inches; dimensions and thicknesses identical to predicate; semi-constrained design. ## 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 Posteriorly Stabilized Tibial Bearing Insert ([K962152](/device/K962152.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}------------------------------------------------ MAY 17 999 # K99 1461 ## Special 510(k) - Device Modification Summary of Safety and Effectiveness for the Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert #### Submission Information | Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp.
59 Route 17
Allendale, NJ 07401-1677 | |--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Marybeth Naughton
Regulatory Affairs Team Member | | Date of Summary Preparation: | April 16, 1999 | | Device Identification: | | | Proprietary Name: | Osteonics® Scorpio™ Total Knee
Relaxed Back P/S Tibial Bearing
Insert | | Common Name: | Knee Prosthesis | | Classification Name and Reference: | Knee Joint, Patellofemorotibial,
Polymer/Metal/Polymer, Semi-
Constrained, Cemented Prosthesis
21 CFR §888.3560 | ### Predicate Device Identification The modified features of the Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Inserts are substantially equivalent to features of the following Osteonics® predicate device, which has been cleared for marketing via the 510(k) process: - Osteonics® Scorpio™ Total Knee Posteriorly Stabilized Tibial Bearing Insert ● (#K962152) ### Device Description The Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert is a modification of the predicate Osteonics® Scorpio™ Total Knee Posteriorly Stabilized Tibial Bearing Insert. {1}------------------------------------------------ The modification involves increasing the posterior radius of the tibial bearing insert to a value of six inches as compared to three inches for the standard Scorpio™ family of tibial bearing inserts. This modification is designed to allow the femur to reach deeper flexion angles by further resisting femoro-tibial distraction and increase ligament tension in the deep flexion range. All other design features of the modified Scorpio™ design tibial bearing insert will remain unchanged. The sizes and UHMWPE thicknesses of the modified tibial bearing inserts will be identical to the predicate tibial bearing insert design. #### Intended Use: The intended use of the modified tibial bearing inserts is identical to that of the unmodified tibial bearing inserts. As with the predicate tibial bearing inserts, the modified tibial bearing inserts are single use devices. They are intended for mating with commercially available Osteonics® Tibial Trays and corresponding posteriorly stabilized femoral and patellar components. The Osteonics® Scorpio™ Posteriorly Stabilized Total Knee Components are intended for cemented fixation. Specific indications for use are as follows: - 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. - Ligamentous instability requiring implant bearing surface geometries with increased constraint. - Absent or non-functioning posterior cruciate ligament. ### Performance Data: A Risk Analysis and R & D Testing have have been performed to demonstrate the substantial equivalence of this tibial bearing insert design to the predicate tibial bearing insert design. ### Statement of Technological Comparison: All features of the Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert are unchanged with the exception of 1) the change posterior radius of the tibial bearing insert from three inches to six inches. All other design features, materials and manufacturing methods will remain unchanged. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white. MAY 1 7 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Marybeth Naughton Requlatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677 Re: K991461 Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert II Requlatory Class: Product Code: JWH Dated: April 22, 1999 Received: April 27, 1999 Dear Ms. Naughton: 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 system being equivalent only to similar device systems labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the qeneral controls provisions of the Act and the following limitations: - The thinnest tibial insert available is the nominal "size 1. 3″ insert, which has a minimum polyethylene thickness under the condyles of 6.25mm. - 2. This device system may not be labeled or promoted for non-cemented use. - 3. All labeling for this device system, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only. {3}------------------------------------------------ Page 2 - Ms. Marybeth Naughton - Any non-cemented fixation of this device system is 4 . considered 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 system for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation. 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 requlations 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 Regulations. 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 information on your responsibilities under the Act may be {4}------------------------------------------------ Page 3 - Ms. Marybeth Naughton obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at feb corr rroc namble (p://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia 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): K99146) Device Name: Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert Indications For Use: The indications for the use of the Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert , in keeping with those of other legally marketed Osteonics® total knee 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. ● - Ligamentous instability requiring implant bearing surface geometries with increased ● constraint. - Absent or non-functioning posterior cruciate ligament. ● (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prescription Use X (Per 21 CFR 801. 109) OR Over-The-Counter Use (Optional Format 1-2- 96) Picollela (Division Sign-Off) Division of General Restorative Devices 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K991461](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K991461) **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