(146 days)
No
The document describes a standard knee replacement system with no mention of AI or ML technology in its design, function, or testing.
Yes.
The device is a total knee replacement system intended for use in knee arthroplasty to treat various degenerative joint diseases and correct functional deformities, which are conditions that impair normal body function and require intervention to restore or improve health.
No
The device is a total knee replacement system, which is a prosthetic implant used for treating degenerative joint diseases and correcting deformities. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like CoCrMo and UHMWPE, which are implanted into the body. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a total knee replacement system, which is an implantable medical device used to surgically replace a damaged knee joint.
- Intended Use: The intended use clearly states it's for knee arthroplasty (joint replacement surgery) in patients with various knee conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
Physica CR total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory 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.
Physica CR knee system is intended for cemented fixation.
Product codes
JWH
Device Description
The Physica CR Knee Replacement System is a total knee replacement system consisting of a femoral component, a UHMWPE tibial liner, a tibial plate, and an all polyethylene patellar component. Modular tibial stems are provide for optional use as needed. The Physica CR knee system devices are intended to be used with bone cement.
The femoral components are made of CoCrMo (ISO 5832-4 / ASTM F75). The articulating surface is polished and with symmetrical condyles. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available.
Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial and lateral hemi-plateau. The liner is attached to the tibial plate through a snap-fit mechanism. The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexion-extension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in a symmetrical version for left and right knees.
The tibial plates and all polyethylene patellar components are the tibial plates and patellar components used for the Physica KR Knee Replacement System (K141934).
Tibial stems can be optionally used and are the same as those cleared for the Physica KR knee system in K141934.
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)
Non-Clinical Testing:
The following tests were performed on Physica CR knee system devices:
- Contact areas and pressures at tibio-femoral and patello-femoral interfaces; ●
- Wear testing: ●
- Constraint tests at tibio-femoral and patello-femoral interfaces.
Fatigue tests on the tibial plate, fatigue resistance of the tibial plate-tibial stem coupling. test on the locking strength between the tibial plate and the tibial liner and static shear test on the patella were performed for the Physica KR system and are applicable to Physica CR knee system.
Mechanical testing was performed on worst case components or constructs. The testing results demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Physica CR knee system to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other. The profiles are rendered in black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6. 2015
Limacorporate S.p.A. % Dr. Stephen Peoples President People & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K151266 Trade/Device Name: Physica CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 8, 2015 Received: September 9, 2015
Dear Dr. Peoples:
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. Iisting 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
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151266
Device Name Physica CR Knee System
Indications for Use (Describe)
Physica CR total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory 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.
Physica CR knee system is intended for cemented fixation.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Summary of Safety and Effectiveness
Date: October 10, 2015
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 – Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512
| Product | Common
Name | Product
Code | Regulation and Classification Name |
|---------------------------|----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Physica CR
knee system | Total Knee
System | JWH | Knee joint Patellofemorotibial
Polymer/Metal/Polymer Semi-
Constrained Cemented Prosthesis per 21
CFR 888.3560 |
Description
The Physica CR Knee Replacement System is a total knee replacement system consisting of a femoral component, a UHMWPE tibial liner, a tibial plate, and an all polyethylene patellar component. Modular tibial stems are provide for optional use as needed. The Physica CR knee system devices are intended to be used with bone cement.
The femoral components are made of CoCrMo (ISO 5832-4 / ASTM F75). The articulating surface is polished and with symmetrical condyles. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available.
Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial and lateral hemi-plateau. The liner is attached to the tibial plate through a snap-fit mechanism. The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexion-extension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in a symmetrical version for left and right knees.
The tibial plates and all polyethylene patellar components are the tibial plates and patellar components used for the Physica KR Knee Replacement System (K141934).
Traditional 510(k) - Physica CR knee system
4
Tibial stems can be optionally used and are the same as those cleared for the Physica KR knee system in K141934.
Intended Use
Physica CR total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory 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.
All components of the Physica CR knee system are intended for cemented fixation.
Predicate Devices
Basis of Substantial Equivalency
The Physica CR knee system components share the same materials, intended use and basic design features as those of the predicate devices. Non-clinical testing demonstrates that the subject components perform at least as well as the cited predicates.
Non-Clinical Testing
The following tests were performed on Physica CR knee system devices:
- Contact areas and pressures at tibio-femoral and patello-femoral interfaces; ●
- Wear testing: ●
- Constraint tests at tibio-femoral and patello-femoral interfaces.
Fatigue tests on the tibial plate, fatigue resistance of the tibial plate-tibial stem coupling. test on the locking strength between the tibial plate and the tibial liner and static shear test on the patella were performed for the Physica KR system and are applicable to Physica CR knee system.
Mechanical testing was performed on worst case components or constructs. The testing results demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Physica CR knee system to the predicate devices.