(319 days)
Not Found
No
The summary describes a mechanical knee implant system and does not mention any AI or ML components or functionalities.
Yes
The device, a total knee system, is intended for total knee replacement due to various medical conditions, which inherently involves treating a disease or injury. Therefore, it serves a therapeutic purpose.
No
The device description and intended use clearly state that this is a system for total knee replacement, an implant, not a tool for diagnosis. The performance studies also focus on material integrity and wear, not diagnostic accuracy.
No
The device description clearly states the device is made of polyethylene and is part of a total knee system, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Proven Gen-Flex™ Total Knee System is a surgical implant designed to replace a damaged knee joint. It is physically implanted into the patient's body.
- Intended Use: The intended use is for total knee replacement due to various conditions affecting the knee joint. This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a device used in vivo (within the body) for treatment, not in vitro (in glass/outside the body) for diagnosis.
N/A
Intended Use / Indications for Use
The Proven Gen-Flex™ Total Knee System is intended for:
- Total knee replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis, and/or 1. post-traumatic degenerative problems.
- Revision of failed previous reconstructions where sufficient bone stock and soft tissue 2. integrity are present.
The device is intended for cemented use only.
Product codes
JWH, OIY
Device Description
The EXp Tibial Inserts and Patellar Components are made of polyethylene to which Vitamin E has been blended. The tibial inserts are available in "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) designs. The patellar components are available Single Peg and Three Peg designs. These implants are part of the Proven Gen-Flex™ Total Knee System and will be used in conjunction with a femoral component and tibial baseplate in total knee arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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)
Non-clinical testing was performed on the EXp Tibial Inserts to assess the interconnection mechanism between the insert and tibial baseplate, and the integrity of the tibial post on the posterior-stabilized design. The inserts were also subjected to knee simulator wear testing per ISO 14243-1; and oxidative stability testing per ASTM F2102, after aging per ASTM F2003 after 10 million cycles of knee simulator wear testing. The testing demonstrates that the EXp Tibial Inserts are substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
StelKast Proven Cemented, Semi-Constrained Total Knee System (K980276), Stelkast Proven Knee System High Flexion Tibial Insert (K063211), Stelkast EXp Acetabular Liner (K094035), Biomet Vanguard® Complete Knee System (K113550)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(k) Summary
| Device Trade Name: | EXp Tibial Inserts and Patellar Components for StelKast's Proven
Gen-Flex™ Total Knee System |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | StelKast, Inc.
200 Hidden Valley Road
McMurray, PA 15317 |
| Contact: | Mr. David Stumpo
Vice President of Product Development
Phone: 724.731.2208
Fax: 724.941.5987
dstumpo@stelkast.com |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
Fax: (202) 552-5798 |
| Date Prepared: | June 30, 2013 |
| Classification: | 21 CFR 888.3560, Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis |
| Class: | II |
| Product Codes: | JWH, OIY |
Indications For Use:
The Proven Gen-Flex™ Total Knee System is intended for:
- Total knee replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis, and/or 1. post-traumatic degenerative problems.
- Revision of failed previous reconstructions where sufficient bone stock and soft tissue 2. integrity are present.
The device is intended for cemented use only.
Device Description:
The EXp Tibial Inserts and Patellar Components are made of polyethylene to which Vitamin E has been blended. The tibial inserts are available in "Cruciate Retaining" (CR) and "Posterior
1
Stabilized" (PS) designs. The patellar components are available Single Peg and Three Peg designs. These implants are part of the Proven Gen-Flex™ Total Knee System and will be used in conjunction with a femoral component and tibial baseplate in total knee arthroplasty.
Predicate Devices:
Comparative information presented in the 510(k) supports the substantial equivalence of the EXp Tibial Inserts and Patellar Components with respect to their intended use, design, materials, range of sizes, method of fixation, and performance.
This 5100k) demonstrates the substantial equivalence of the EXp Tibial Inserts and Patellar Components to the following predicate devices:
- StelKast Proven Cemented, Semi-Constrained Total Knee System (K980276) .
- Stelkast Proven Knee System High Flexion Tibial Insert (K063211) .
- Stelkast EXp Acetabular Liner (K094035) .
- Biomet Vanguard® Complete Knee System (K113550) .
Preclinical Testing:
Non-clinical testing was performed on the EXp Tibial Inserts to assess the interconnection mechanism between the insert and tibial baseplate, and the integrity of the tibial post on the posterior-stabilized design. The inserts were also subjected to knee simulator wear testing per ISO 14243-1; and oxidative stability testing per ASTM F2102, after aging per ASTM F2003 after 10 million cycles of knee simulator wear testing. The testing demonstrates that the EXp Tibial Inserts are substantially equivalent to legally marketed predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper half of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G609 Silver Spring, MD 20993-0002
August 5. 2013
StelKast, Incorporated % Mr. David Stumpo Vice President of Product Development 200 Hidden Valley Road McMurray, Pennsylvania 15317
Rc: K122883
Trade/Device Name: EXp Tibial Inserts and Patellar Components for StelKast's Proven Gene-Flex Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: July 25, 2013 Received: July 26, 2013
Dear Mr. Stumpo:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; howcver, that device fabeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/McdicalDcviccs/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1/1
Indications for Use 4.
510(k) Number (if known): _K122883
Device Name: EXp Tibial Inserts and Patellar Components for StelKast's Proven Gen-Flex™ Total Knee System
The Proven Gen-Flex™ Total Knee System is intended for:
- し、 Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis. and/or post-traumatic degenerative problems.
- Revision of failed previous reconstructions where sufficient bone stock and soft 2. tissue integrity are present.
The device is intended for cemented use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D. . .
Division of Orthopedic Devices 1.1 - - -! " " . . -- -- -