(87 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for knee replacement and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on preclinical mechanical testing and equivalence to predicate devices, not on algorithmic performance.
Yes
The device aids in the reduction or relief of pain and improved knee function for patients with severe knee pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a total knee system, an implant used in knee arthroplasty to replace a damaged knee joint. Its purpose is to treat severe knee pain and disability, not to diagnose a condition.
No
The device description clearly states it is a "fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations" and lists physical components like "femoral component, tibial insert, tibial tray and patellar component." This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee prosthesis (femoral component, tibial insert, tibial tray, patellar component). These are physical implants, not reagents, instruments, or systems used to examine specimens from the human body.
- No mention of biological specimens: There is no indication that this device interacts with or analyzes biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Focus on mechanical function: The performance studies and descriptions focus on the mechanical characteristics and function of the implant within the body.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition by replacing a joint.
N/A
Intended Use / Indications for Use
The Stabil Orthopaedic Solutions Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature 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.
The Stabil Orthopaedic Solutions Total Knee System 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. The Stabil Orthopaedic Solutions Total Knee System is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Stabil Orthopaedic Solutions Total Knee System is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Stabil Orthopaedic Solutions Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patients
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)
Extensive preclinical performance testing was conducted and substantial equivalence determined per K142649 and K150783. The components of the subject device are identical to the predicate device, and therefore the predicate device testing demonstrates substantial equivalence for the results confirm that all components of the Stabil Orthopaedic Solutions Total Knee System exhibit the appropriate mechanical characteristics for total knee joint replacement, and are substantially equivalent to the predicate devices.
- Fatigue performance of the tibial tray 0
- . Interlock mechanism strength of the tibial tray and insert
- o Shear fatigue strength of the tibial insert post
- Tibiofemoral contact area and stress
- Tibiofemoral constraint
- . Patellofemoral constraint
- Range of motion
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Stabil Orthopaedic Solutions, LLC Jim Moore CEO 20031 Henrici Road Oregon City, Oregon 97045
February 15, 2019
Re: K183225
Trade/Device Name: Stabil Orthopaedic Solutions 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: November 19, 2018 Received: November 20, 2018
Dear Jim Moore:
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.
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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Daniel S. Ramsey -S 2019.02.15 16:34:58 -05'00'
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183225
Device Name Stabil Orthopaedic Solutions Total Knee System
Indications for Use (Describe)
The Stabil Orthopaedic Solutions Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature 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.
The Stabil Orthopaedic Solutions Total Knee System 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. The Stabil Orthopaedic Solutions Total Knee System is designed 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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Stabil Orthopaedic Solutions Total Knee System
510(k) Summary
The following 510(k) Summary is provided in accordance with 21 CFR 807.92.
510(k) Owner and Registration 6.1
| Owner's Name: | Stabil Orthopaedic Solutions, LLC |
|---|---|
| Address: | 20031 Henrici Road., Oregon City, OR 97045 |
| Phone Number: | (503) 421-1251 |
| Fax Number: | N/A |
| Date Summary Prepared: | November 15, 2018 |
| Establishment Registration Number: | N/A |
6.2 510(k) Contact
| Contact: | Jim Moore |
|---|---|
| Address: | 20031 Henrici Road |
| Oregon City, OR 97045 | |
| Phone Number: | (503) 421-1251 |
| Fax Number: | N/A |
| Contact Person: | Jim Moore |
6.3 Device Name and Classification
| Device Trade Name: | Stabil Orthopaedic Solutions Total Knee System |
|---|---|
| Device Common Name: | Total Knee Replacement |
| Regulation Number and Description: | 21 CFR 888.3560 |
| Device Class: | Class II |
| Product Codes: | JWH |
| Advisory Panel: | 87 (Orthopedic) |
Legally Marketed Predicate 6.4
Stabil Orthopaedic Solutions is utilizing the Progressive Orthopaedic Total Knee System as the predicate device (K142649/K150783). The Stabil Orthopaedic Solutions Total Knee System features component designs, materials, indications, and manufacturing methods that are identical to the Progressive Orthopaedic Total Knee System.
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6.5 Device Description
The Stabil Orthopaedic Solutions Total Knee System is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version of the Stabil Orthopaedic Solutions Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
6.6 Intended Use
The Stabil Orthopaedic Solutions Total Knee System is identical to the predicate Progressive Orthopaedic Total Knee System. The indications for use are also identical.
The Stabil Orthopaedic Solutions Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature 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.
The Stabil Orthopaedic Solutions Total Knee System 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. The Stabil Orthopaedic Solutions Total Knee System is designed for cemented use only.
6.7 Summary of Technological Characteristics
The Stabil Orthopaedic Solutions Total Knee system is identical to the predicate Progressive Orthopaedic Total Knee System. Both devices are manufactured from identical materials, possess the same sizes, and feature the same packaging and sterilization processes. Extensive preclinical testing was performed on the predicate devices per K142649 and K150783 and found substantially equivalent. The performance tests are listed below and used herein to establish substantial equivalence (Section 19 Performance Testing – Bench)
Given that the subject device is identical to the predicate, the substantially equivalent to the predicate systems (K142649/K150783).
6.8 Performance Testing
Extensive preclinical performance testing was conducted and substantial equivalence determined per K142649 and K150783. The components of the subject device are identical to the predicate device, and therefore the predicate device testing demonstrates substantial equivalence for the results confirm that
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all components of the Stabil Orthopaedic Solutions Total Knee System exhibit the appropriate mechanical characteristics for total knee joint replacement, and are substantially equivalent to the predicate devices.
- Fatigue performance of the tibial tray 0
- . Interlock mechanism strength of the tibial tray and insert
- o Shear fatigue strength of the tibial insert post
- Tibiofemoral contact area and stress
- Tibiofemoral constraint
- . Patellofemoral constraint
- Range of motion
Conclusions 6.9
The Stabil Orthopaedic Solutions Total Knee System is identical to the predicate Progressive Orthopaedic Total Knee System. The subject device has the same design features, materials, and indications for use as the predicate devices. The testing performed for the predicate that the Stabil Orthopaedic Solutions Total Knee System is safe for clinical use.
The Stabil Orthopaedic Solutions Total Knee System is substantially equivalent to the predicate device.