# K201084: Physica system

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Dec 14, 2020 after 235 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: 12 generations back to K810258 (1981). 133 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141934: Physica KR Knee System, Lima Corporate S.P.A. (2015) Summary page 5.
- K193284: Physica LMC Knee System, Lima Corporate S.P.A. (2020) Summary page 5.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 5.
- K072160: Nexgen Trabecular Metal Tibial Tray, Zimmer, Inc. (2007) Summary page 5.

## Most influential descendants
- K210554: Physica system (2021), 2 descendants of its own
- 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
- K213381: Physica system (2021), 0 descendants of its own
- K211938: Physica LMC Knee System (2021), 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 - osteoarthritis - traumatic arthritis, and - 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. Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of the TT Tibial Plate that is intended for uncemented use. Tibial liners can be used with cemented or uncemented tibial components.

Source page: https://510kreport.com/device/K201084
Methodology: https://510kreport.com/methodology