(90 days)
SurgTech-MALUC (K162125)
No
The summary describes a conventional total knee replacement system with standard components and instrumentation. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or performance studies.
No.
The device is an implantable prosthetic device (total knee system) for surgical replacement of the knee joint. While it aims to restore function and relieve pain, it's a surgical implant rather than a therapeutic device in the sense of delivering therapy.
No.
The device is a total knee replacement system intended to treat severe knee pain and disability, not to diagnose conditions.
No
The device description explicitly states the system consists of physical components made of CoCr alloy and polyethylene, along with necessary instrumentation for implantation. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Surg Tech GENOLL™ system is a surgical implant used to replace a damaged knee joint. It is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a total knee replacement system (femoral component, tibial baseplate, tibial bearing insert, patella). These are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
- Performance Studies: The performance studies listed are related to the mechanical properties and safety of the implant (fatigue, constraint, contact area, endotoxins), not diagnostic accuracy.
In summary, the Surg Tech GENOLL™ system is a surgical implant used for treatment, not a device used to diagnose a condition.
N/A
Intended Use / Indications for Use
The Surg Tech GENOLL™ system is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only.
Product codes
JWH
Device Description
The SurgTech GENOLL"Total Knee System is used for total knee arthroplasty in skeletally mature individuals. The system consists of a CoCr alloy Posterior Stabilized (PS) femoral component (10 sizes, Left and Right), a CoCr alloy tibial baseplate (10 sizes), a conventional polyethylene PS tibial bearing insert (5 sizes with 5 thicknesses each) and a conventional polyethylene patella (3 sizes). Instrumentation necessary for proper implantation is also included.
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
skeletally mature individuals
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 for the following performance characteristics:
- Baseplate Fatigue (ASTM F1800)
- Constraint (ASTM F1223)
- Contact Area (ASTM F2083, ASTM F1672)
- PS Post Fatigue (ASTM F1814)
- Tibial Insert/Baseplate Disassembly (ASTM F2083, ASTM F1814)
- Bacterial endotoxins (USP )
Clinical testing was not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Zimmer-NexGen LPS Flex (K991581), Otis Biotech-Prolixus (K170534)
Reference Device(s)
SurgTech-MALUC (K162125)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2019
SurgTech, Inc. % Kellen Hills Quality and Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, Connecticut 06484
Re: K191192
Trade/Device Name: SurgTech GENOLL™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: April 29, 2019 Received: May 3, 2019
Dear Kellen Hills:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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, however, that device labeling 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SurgTech GENOLL™ Total Knee System
Indications for Use (Describe)
The Surg Tech GENOLL™ system is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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GENOLL Total Knee System
3
| (a)(1) | Date Prepared: | April 29, 2019 |
|---|---|---|
| Submitted By: | SurgTech, Inc. | |
| 24600 Center Ridge Road, Suite 195 | ||
| Westlake, OH 44145 | ||
| Phone: | 440-899-2922 | |
| Contact: | Robert Gutierrez | |
| Prepared By: | Orchid Design | |
| 80 Shelton Technology Center, | ||
| Shelton, CT 06484 | ||
| Phone: | (203) 922 0105 | |
| (a)(2) | Proprietary Name: | SurgTech GENOLLTM Total Knee System |
| Common Name: | Total Knee Prosthesis | |
| Classification Name and Reference: | 21CFR 888.3560 - Knee joint | |
| patellofemorotibial | ||
| polymer/metal/polymer semi- | ||
| constrained cemented prosthesis | ||
| Product Code: | JWH | |
| (a)(3) | Predicate Devices: | |
| Primary: | Zimmer-NexGen LPS Flex (K991581) | |
| Additional: | Otis Biotech-Prolixus (K170534); | |
| Reference: | SurgTech-MALUC (K162125); |
(a)(4) Device Description:
The SurgTech GENOLL"Total Knee System is used for total knee arthroplasty in skeletally mature individuals. The system consists of a CoCr alloy Posterior Stabilized (PS) femoral component (10 sizes, Left and Right), a CoCr alloy tibial baseplate (10 sizes), a conventional polyethylene PS tibial bearing insert (5 sizes with 5 thicknesses each) and a conventional polyethylene patella (3 sizes). Instrumentation necessary for proper implantation is also included.
The purpose of this submission is to gain initial marketing authorization in the United States.
(a)(5) Indications for Use:
The SurgTech GENOLL™ system is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary
4
traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only.
-
(a)(6) Comparison of Technological Characteristics:
The SurgTech GENOLL Total Knee System is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, packaging, sterilization and mechanical performance. The technological characteristics do not raise any new questions of safety and efficacy. -
(b)(1) Non-clinical testing:
The subject devices were evaluated for the following performance characteristics: -
Baseplate Fatigue (ASTM F1800)
-
Constraint (ASTM F1223) ●
-
Contact Area (ASTM F2083, ASTM F1672)
-
PS Post Fatigue (ASTM F1814) ●
-
0 Tibial Insert/Baseplate Disassembly (ASTM F2083, ASTM F1814)
-
Bacterial endotoxins (USP )
(b)(2) Clinical testing:
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
(b)(3) Conclusions:
Based on the information provided in this premarket notification, we believe that the subject SurgTech GENOLL Total Knee System demonstrates substantial equivalence to the identified predicate devices.