(158 days)
To identify the Reference Device(s) K/DEN number, I need to find a section titled "Reference Device(s)" which usually contains K/DEN numbers for devices that are used as references but not predicates.
Upon reviewing the provided text, I found the section:
Reference Device(s)
Not Found
Since the text explicitly states "Not Found" under the "Reference Device(s)" heading, it means there are no reference devices listed with K/DEN numbers in this document.
Therefore, the output is:
Not Found
No
The document describes a physical medical device (knee replacement components) made of UHMWPE with a specific geometry and fixation method. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is described as a replacement for the patellar articulating surface of the knee joint to treat painful and disabling joint diseases. It is explicitly indicated for revision of previous unsuccessful knee replacements, which aims to improve the patient's condition. This aligns with the definition of a therapeutic device as something intended to treat or alleviate a medical condition.
No
Explanation: The device is described as a replacement for the patellar articulating surface of the knee joint, a single-use device intended for cemented application. Its stated purpose is to "simulate the natural function of the knee joint" and address conditions like painful joint disease and post-traumatic loss of knee joint function, which are problems the device is intended to fix, not diagnose.
No
The device description clearly states the components are fabricated from ultra-high molecular weight polyethylene (UHMWPE) and describes their physical geometry and features, indicating they are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are implantable devices intended for surgical replacement of the patellar articulating surface in the knee joint. They are used in total knee replacement procedures.
- Lack of Diagnostic Activity: The device does not perform any tests on biological samples to diagnose a condition. Its function is purely mechanical and structural, replacing a damaged part of the body.
Therefore, this device falls under the category of a medical device (specifically, an orthopedic implant), but not an in vitro diagnostic device.
N/A
Intended Use / 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. .
Product codes
JWH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Applicable performance testing demonstrates that the subject devices perform at least as well as, if not better than, commercially available designs.
Key Metrics
Not Found
Predicate Device(s)
Osteonics® Scorpio™ Total Knee All-Polyethylene Patellar Components - concentric dome design, Johnson and Johnson® P.F.C.® Cruciate Sacrificing Patellar Component
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
0
Osteonics" Scorpio™ Total Knee Universal Dome and Recessed Patellar Components
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