# K210554: Physica system

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Apr 6, 2021 after 40 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K810258 (1981). 134 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201084: Physica system, Lima Corporate S.P.A. (2020) Summary page 5.
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known, Biomet, Inc. (2004) Summary page 6.
- K050222: Vanguard Anterior Stabilized Tibial Bearings, Biomet, Inc. (2005) Summary page 6.
- K060303: Vanguard PS Open Box Porous Femoral Components, Biomet Manufacturing Corp (2006) Summary page 6.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012)

## Most influential descendants
- K243615: Physica Porous Femoral Components (2024), 1 descendant of its own
- K250980: Physica System (Physica CR Porous Femoral components) (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K210554
Methodology: https://510kreport.com/methodology