(26 days)
No
The summary describes a knee implant system made of a specific material and does not mention any AI/ML capabilities or data processing.
Yes.
The device is intended for total knee arthroplasty to treat painful, disabling joint diseases and deformities, which are therapeutic interventions.
No.
The document states that the Scorpio® NRG® Knee System is a device intended for total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly states it comprises "femoral and tibial insert components" and is a "sterile, single-use device intended for total knee arthroplasty," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "total knee arthroplasty," which is a surgical procedure to replace the knee joint. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components are implants (femoral and tibial inserts) designed to be surgically placed within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the examination of specimens outside the body.
The Scorpio® NRG® Knee System is a surgical implant used in a therapeutic procedure, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Scorpio® NRG® Knee System is a sterile, single-use device intended for total knee arthroplasty.
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 Posterior Stabilized Components:
- . 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.
Product codes
JWH
Device Description
The Scorpio® NRG® Knee System comprises a series of femoral and tibial insert components. The subject Scorpio® NRG® X3® inserts are available in cruciate retaining (CR) and posterior stabilized (PS) designs and are used for the replacement of the bearing/articulating surfaces of the proximal tibia. The modification to the subject devices is the sequentially crosslinked and annealed X3® UHMWPE material process.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
AUG 1 5 2007
510(k) Summary of Safety and Effectiveness for the
| Proprietary Name: | Scorpio® NRG® Knee System |
|---|---|
| Common Name: | Total Knee Joint Replacement Prosthesis |
| Classification Name and Reference | 888.3560 - Knee joint, patellofemorotibial, |
| polymer/metal/polymer semi-constrained cemented | |
| prosthesis | |
| Regulatory Class: | Class II |
| Device Product Code: | JWH - prosthesis, knee, patellofemorotibial, semi- |
| constrained, cemented, polymer/metal/polymer | |
| For Information contact: | Patricia Setti-LaPerch |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07430 | |
| Phone: (201) 831-5938 | |
| Fax: (201) 831-4938 | |
| E-Mail: Patricia.LaPerch@stryker.com | |
| Date Summary Prepared: | July 19, 2007 |
.
1
Device Description
The Scorpio® NRG® Knee System comprises a series of femoral and tibial insert components. The subject Scorpio® NRG® X3® inserts are available in cruciate retaining (CR) and posterior stabilized (PS) designs and are used for the replacement of the bearing/articulating surfaces of the proximal tibia. The modification to the subject devices is the sequentially crosslinked and annealed X3® UHMWPE material process.
Intended Use:
The Scorpio® NRG® Knee System is a sterile, single-use device intended for total knee arthroplasty.
Indications
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 Posterior Stabilized Components:
- . 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.
Substantial Equivalence:
The subject Scorpio NRG X3 inserts are a modification to the Scorpio NRG System cleared in K042343 [Scorpio NRG Knee System (Cruciate Retaining Components)] and K030978 (Scorpio NRG Knee System Posterior Stabilized). The determination of the substantial equivalence for the Scorpio NRG X3 inserts is based on this line extension's identical intended use and indications for use and similar design to the previously cleared Scorpio NRG Knee System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three wavy lines forming the staff and the snakes, and the text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2007
Howmedica Osteonics Corp. % Ms. Patricia Setti-LaPerch Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K071991
Trade/Device Name: Scorpio® NRG® Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 19, 2007 Received: July 20, 2007
Dear Ms. Setti-LaPerch:
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 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
3
Page 2 - Ms. Patricia Setti-LaPerch
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 (240) 276-0120. 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 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara boehme
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Ko71991
Device Name: Scorpio® NRG® Knee System
Indications
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 Posterior Stabilized Components:
- 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.
Prescription Use
×
OR Over-the-Counter Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Toubare Bneim
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071991