(237 days)
Scorpio® Total Knee, Scorpio® Scorpio-flex™ Tibial Inserts
Scorpio® Total Knee, Scorpio® Scorpio-flex™ Tibial Inserts
No
The summary describes a mechanical knee implant system and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device, a total knee system, is intended to treat painful, disabling joint disease and restore function, which aligns with the definition of a therapeutic device.
No
The device is a knee replacement system used to treat painful and disabling joint disease, not to diagnose a condition.
No
The device description explicitly states it includes "femoral components and tibial insert components," which are physical hardware components of a knee replacement system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical procedure (total knee arthroplasty) to replace joint components and address painful, disabling joint disease. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device components are described as parts of a total knee system used for replacing bearing and articulating surfaces. This aligns with a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Scorpio® NRG™ Knee System is a medical device used for surgical treatment.
N/A
Intended Use / Indications for Use
The Scorpio® NRG™ Knee System components are for use in total knee arthroplasty for 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 with the ligamentous structures can be returned to adequate function and stability; and/or revision of previous unsuccessful knee replacement or other procedure.
Additional indications for the Posterior stabilized components include: Ligamentous instability requiring implant bearing surface geometries with increased constraint; and/or an absent or non-functioning posterior cruciate ligament.
Product codes
JWH
Device Description
The device includes femoral components and tibial insert components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A risk analysis and Research and Development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes range of constrained testing, analysis of tibial insert post stress and contact stress/area analysis. The results demonstrate equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Scorpio® Total Knee, Scorpio® Scorpio-flex™ Tibial Inserts
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.
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NOV 2 0 2003
Summary of Safety and Effectiveness
| Contact Person: | Denise Duchene
Sr. Regulatory Affairs Specialist
Howmedica Osteonics Corp.
59 Route 17 South
Allendale, NJ 07401
(201) 831-5612 (Phone)
(201) 831-6038 (FAX) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 14, 2003 |
| Device: | Scorpio® NRG™ Knee |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-
constrained; Cemented prosthesis - Class II -21 CFR 888.3560 |
| Predicate Devices: | Scorpio® Total Knee
Scorpio® Scorpio-flex™ Tibial Inserts |
| Indications for Use: | The Scorpio® NRG™ Knee System components are for use in total
knee arthroplasty for 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 with
the ligamentous structures can be returned to adequate function
and stability; and/or revision of previous unsuccessful knee
replacement or other procedure. |
| | Additional indications for the Posterior stabilized components
include:
Ligamentous instability requiring implant bearing surface
geometries with increased constraint; and/or an absent or non-
functioning posterior cruciate ligament. |
| Proposed Modification: | Redesign the femoral and tibial insert component dimensions to
provide for increased range of motion. |
| Device Description: | The device includes femoral components and tibial insert
components of a total knee system. These components are used for
the replacement of the bearing and/or articulating surfaces of the
distal femur, proximal tibia to relieve pain, instability and the
restriction of motion due to degenerative bone disease, including
osteoarthritis, rheumatoid arthritis, failure of other devices or
trauma. |
1
Summary of Data:
A risk analysis and Research and Development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes range of constrained testing, analysis of tibial insert post stress and contact stress/area analysis. The results demonstrate equivalence.
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NOV 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401
Re: K030978
·
Trade/Device Name: Scorpio NRG Knee System Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Codes: JWH Dated: August 21, 2003 Received: August 22, 2003
Dear Ms. Duchene:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Ms. Denise Duchene
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 (vr (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celua M. Witten, Ph.D., M.D.
Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
K030978
Device Name: Scorpio® NRG™ Knee System Components
Indications for Use:
The Scorpio "NRG" Knee System components are for use in total knee arthroplasty as a result of:
- 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; .
Additional indications for the posterior stabilized components include:
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint
- Absent or non-functioning posterior cruciate ligament ●
These components are single use only and are intended for implantation with bone cement.
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE GE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the-Counter Use OR (Per 21 CFR 801.109)