(20 days)
Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease including
- o osteoarthritis
- o traumatic arthritis, and
- o avascular necrosis (not applicable to Physica TT Tibial Plate);
- · 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.
Additional indications for Physica LMC component are:
-
. Moderate varus, valgus, or flexion deformities.
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.
AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon.
Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.
Tibial liners can be used with cemented or uncemented tibial or femoral components.
Physica LMC Knee System is a modular knee system which consists of Physica LMC tibial liner, made of UHMWPE or LimaVit, used in combination with a Physica CR femoral component, Physica tibial plate, cemented or uncemented versions, Physica patellar component, made of standard UHMWPE or LimaVit and Physica tibial stem, that were cleared as part of the Physica Knee System in K141934, K151266 and K201084.
The Physica LMC knee system is intended to be used in patients with or without a functioning posterior cruciate ligament.
This document is a 510(k) premarket notification decision letter from the FDA regarding the Physica LMC Knee System. It is a regulatory approval document and does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), or clinical/non-clinical testing data to prove the device meets acceptance criteria.
The document explicitly states:
- "Non-Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."
- "Clinical testing was not necessary to demonstrate substantial equivalence of the Physica LMC Knee System to the predicate devices."
Therefore, I cannot provide the requested information. The 510(k) summary only discusses changes to the indications for use and surgical technique, asserting substantial equivalence based on these changes to already cleared predicate devices, rather than presenting new performance data.
§ 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.