(107 days)
Not Found
No
The summary describes a traditional knee implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a total knee arthroplasty system intended to alleviate pain and restore function in patients with various knee conditions, which are therapeutic goals.
No
Explanation: The device description clearly states its purpose is to replace articulating surfaces of the knee joint and alleviate pain, which identifies it as a treatment device, not a diagnostic one. Diagnostic devices are used to identify medical conditions.
No
The device description clearly states it includes femoral, tibial, and patellar components, which are physical hardware implants. The performance studies also describe bench testing on these physical components.
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 the articulating surfaces of the knee joint. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a system of physical components (femoral, tibial, and patellar) designed to be implanted in the knee. This aligns with a medical device for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory analysis.
In summary, the Responsive Orthopedics Total Knee Arthroplasty System is a surgical implant used for treating knee conditions, not a device used for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
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.
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 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)
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
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.
K943462, K961685, K032151, K950010, K093552, K932837
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/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
1
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 Street |
| Wayzata, 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.
4
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.