(100 days)
Physica knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease: including osteoarthritis, 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.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for:
- · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint.
Physica knee system is intended for cemented fixation.
Physica PS is a modular knee system which consists of a Physica PS femoral component and a Physica PS tibial liner. These devices are used in combination with a Physica tibial plate, a Physica patellar component and, if required, a Physica tibial stem that were cleared as part of the Physica KR knee system in K141934. The Physica PS knee system components are intended to be used with bone cement.
The femoral components are made of CoCrMo alloy (ISO 5832-4 / ASTM F75). The articulating surface is polished and has symmetrical condyles. The femoral component features an open box, designed to contain the post of the tibial liner, and an asymmetrical femoral cam, intended to articulate with the liner post. Conformity between the inner surface of the components and the resected bone provide stability. Two pegs (ISO 5832-12 / ASTM F1537) can be optionally attached to the femoral component if additional fixation is required. 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. In its central part, the liner features a tibial post intended to articulate with the cam of the femoral component. 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, all polyethylene patellar components and the tibial stems are the same devices as used for the Physica KR Knee System (K141934) and Physica CR Knee System (K151266).
I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) premarket notification letter and a summary of safety and effectiveness for a knee implant system. It discusses the device's indications for use, materials, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
Specifically, it does not provide:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Information about a study involving sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets or how ground truth for training was established.
The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Physica PS knee system to the predicate devices." This further confirms the absence of the type of clinical or performance study details you are asking for, which are typically associated with AI/ML device evaluations.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2015
Limacorporate S.p.A. % Dr. Stephen Peoples President Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K152008 Trade/Device Name: Physica PS 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: October 2, 2015 Received: October 5, 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, 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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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 Orthopedics Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Physica PS knee system
Indications for Use (Describe)
Physica knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease: including osteoarthritis, 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.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for:
- · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint.
Physica knee system is intended for cemented fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Summary of Safety and Effectiveness
Date: October 07, 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 | CommonName | ProductCode | Regulation and Classification Name |
|---|---|---|---|
| Physica PSknee system | Total KneeSystem | JWH | Knee joint PatellofemorotibialPolymer/Metal/Polymer Semi-Constrained Cemented Prosthesis per 21CFR 888.3560 |
Description
Physica PS is a modular knee system which consists of a Physica PS femoral component and a Physica PS tibial liner. These devices are used in combination with a Physica tibial plate, a Physica patellar component and, if required, a Physica tibial stem that were cleared as part of the Physica KR knee system in K141934. The Physica PS knee system components are intended to be used with bone cement.
The femoral components are made of CoCrMo alloy (ISO 5832-4 / ASTM F75). The articulating surface is polished and has symmetrical condyles. The femoral component features an open box, designed to contain the post of the tibial liner, and an asymmetrical femoral cam, intended to articulate with the liner post. Conformity between the inner surface of the components and the resected bone provide stability. Two pegs (ISO 5832-12 / ASTM F1537) can be optionally attached to the femoral component if additional fixation is required. 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. In its central part, the liner features a tibial post intended to articulate with the cam of the femoral component. 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.
Traditional 510(k) - Physica PS knee system
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The tibial plates, all polyethylene patellar components and the tibial stems are the same devices as used for the Physica KR Knee System (K141934) and Physica CR Knee System (K151266).
Intended Use
Physica 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.
In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for:
- · Absent or not-functioning posterior cruciate ligament;
- · Severe antero-posterior instability of the knee joint.
Predicate Devices
- Physica KR (Limacorporate, K141934); ●
- Physica CR (Limacorporate, K151266); ●
- Vega System (Aesculap, K121879): ●
- Journey BCS (Smith & Nephew, K042515); .
- . Vanguard PS (Biomet, K113550).
Basis of Substantial Equivalency
The Physica PS knee system components share the same materials, intended use and basic design features 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, applicable to Physica PS knee system, were performed:
- Contact areas and pressures at the femoral-tibial coupling; ●
- Contact areas and pressures at the femoral-patellar coupling; ●
- Constraint at the femoral-patellar coupling; ●
- Wear test:
- Shear fatigue testing of the UHMWPE tibial post;
- Fatigue tests on the tibial plate;
- Fatigue resistance of the tibial plate-tibial stem coupling;
- Locking strength between the tibial plate and the tibial liner;
- Static shear test on the patella. ●
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Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Physica PS knee system to the predicate devices.
§ 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.