(107 days)
The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- · inflammatory degenerative joint disease including rheumatoid arthritis;
- · correction of functional deformity:
- · revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.
The Responsive Orthopedics Total Knee Arthroplasty System is a total knee system for the restoration of alignment, stability and range of motion, and alleviation of pain, by replacing the articulating surfaces of the knee joint. The system includes femoral, tibial and patellar components available in cruciate retaining, ultra-conforming cruciate sacrificing, medial-pivot cruciate sacrificing and posterior stabilizing versions.
This document is a 510(k) summary for the Responsive Orthopedics Total Knee Arthroplasty System. It serves as a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already legally marketed. As such, it focuses on demonstrating equivalence rather than proving novel efficacy or meeting specific acceptance criteria based on clinical outcomes.
Therefore, many of the requested items related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) are not applicable to this type of device submission. This device is a prosthetic implant, and its performance is evaluated through bench testing to ensure mechanical properties and safety are comparable to existing, legally marketed devices.
Here's a breakdown of the information that can be extracted or deduced from the provided text, addressing the closest relevant points:
1. A table of acceptance criteria and the reported device performance
This document does not present "acceptance criteria" or "reported device performance" in the typical sense of a diagnostic or AI device's clinical efficacy. Instead, it relies on demonstrating substantial equivalence to predicate devices through various bench tests that ensure the mechanical integrity and safety of the knee implant. The "acceptance criteria" here are implicitly the standards set by the predicate devices and the relevant ASTM standards for mechanical performance. The "reported device performance" is that it passed these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance per ASTM Standards: | All performed tests were successful: |
| Tibial Baseplate Fatigue (ASTM F1800) | Responsive Orthopedics TKA System passed this testing. |
| UHMWPE Tibial Bearing Components (minimum thickness justification) | Responsive Orthopedics TKA System met justification requirements. |
| Posterior-Stabilized Tibial Bearing Component Shear Fatigue | Responsive Orthopedics TKA System passed this testing. |
| Range of Motion and Constraint (ASTM F1223) | Responsive Orthopedics TKA System passed this testing. |
| Tibiofemoral Contact Area/Stress (ASTM F2083) | Responsive Orthopedics TKA System passed this testing. |
| Component Interlock Strength (ASTM F1814) | Responsive Orthopedics TKA System passed this testing. |
| Substantial Equivalence: | Device is substantially equivalent to predicate devices in function, design, performance, material, and intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: This is not applicable in the context of clinical testing for diagnostic performance. For the bench tests, the "sample size" would refer to the number of physical device components tested, but this specific number is not provided in the summary.
- Data provenance: Not applicable to this type of bench testing. The testing is performed on physical prototypes of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as established by experts (e.g., radiologists) is for diagnostic devices where human interpretation is involved. This device is a mechanical implant subjected to engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies, particularly for diagnostic accuracy, which is not the focus of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance is compliance with established engineering and material standards (e.g., ASTM F1800, F648, F1223, F2083, F1814) and demonstrating mechanical properties comparable to the predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a machine learning "training set".
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Responsive Orthopedics LLC % Jude Paganelli Cor Medical Ventures LLC 101 North Acacia Avenue, Suite 106 Solana Beach, California 92075
Re: K150496 Trade/Device Name: Responsive Orthopedics Total Knee Arthroplasty 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 Dated: March 13, 2015 Received: March 16, 2015
Dear Jude Paganelli:
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, 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 requirements, including, but not limited to: registration and listing (21 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
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Page 2 -Jude Paganelli
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150496
Device Name
Responsive Orthopedics Total Knee Arthroplasty System
Indications for Use (Describe)
The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- · inflammatory degenerative joint disease including rheumatoid arthritis;
- · correction of functional deformity:
- · revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The Responsive Orthopedics Total Knee Arthroplasty System is 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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SECTION 5
510(K) SUMMARY
SUBMITTER:
Submitted By:
| Company Name: | Responsive Orthopedics LLC |
|---|---|
| Address: | 1755 Concordia StreetWayzata, MN 55391 |
| Telephone: | 858-774-7891 |
CONTACT PERSON: Jude Paganelli
DATE PREPARED: February 23, 2015
TRADE NAME: Responsive Orthopedics Total Knee Arthroplasty System
COMMON NAME: RO Knee System
CLASSIFICATION NAME: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. (21 CFR 888.3560)
PRODUCT CODE: JWH
SUBSTANTIAL EQUIVALENCE:
The Responsive Orthopedics Total Knee Arthroplasty System is substantially equivalent to the predicate devices in all facets including: function, design, performance, material, and intended use. The predicate devices for the Responsive Orthopedics Total Knee Arthroplasty System are:
DePuy Sigma® Knee System (K943462, K961685, K032151, K950010) Wright Medical Technology EVOLUTION™ Medial Pivot (K093552) Consensus Knee System (K932837)
DEVICE DESCRIPTION:
The Responsive Orthopedics Total Knee Arthroplasty System is a total knee system for the restoration of alignment, stability and range of motion, and alleviation of pain, by replacing the articulating surfaces of the knee joint. The system includes femoral, tibial and patellar components available in cruciate retaining, ultra-conforming cruciate sacrificing, medial-pivot cruciate sacrificing and posterior stabilizing versions.
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MATERIALS:
The RO TKA femoral components and tibial trays are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75.
The RO TKA poly inserts and patella components are manufactured from noncrosslinked GUR 1050 Ram Extruded UHMWPE conforming to ASTM F648.
INDICATIONS FOR USE:
The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, . traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis:
- . correction of functional deformity;
- revision procedures where other treatments or devices have failed; and . treatment of fractures that are unmanageable using other techniques.
The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.
PERFORMANCE TESTING:
The following bench testing was performed on the Responsive Orthopedics Total Knee Arthroplasty System:
Tibial Baseplate Fatique Testing per ASTM F1800 UHMWPE Tibial Bearing Components (minimum thickness justification) Posterior-Stabilized Tibial Bearing Component Shear Fatigue Testing Range of Motion and Constraint Testing per ASTM F1223 Tibiofemoral Contact Area/Stress per ASTM F2083 Component Interlock Strength per ASTM F1814
CONCLUSIONS:
The Responsive Orthopedics Total Knee Arthroplasty System has shown to be substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing and comparison to predicate devices.
N/A