# K250980: Physica System (Physica CR Porous Femoral components)

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: May 22, 2025 after 52 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: 15 generations back to K810258 (1981). 136 ancestors in all.
No later device cites it as a predicate yet.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243615: Physica Porous Femoral Components, Lima Corporate S.P.A. (2024) Summary page 6.
- K210554: Physica system, Lima Corporate S.P.A. (2021) Summary page 6.
- K151266: Physica CR Knee System, Lima Corporate S.P.A. (2015) Summary page 5.

## 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, PS Pro and HPS components are also indicated for: • Absent or not-functioning posterior cruciate ligament; • Severe antero-posterior instability of the knee joint. Additional indications for Physica HPS component are: • Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. • The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. • Collagen disorders, and/or avascular necrosis of the femoral condyle. • Moderate varus, valgus, or flexion deformities. 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. Tibial liners can be used with cemented or uncemented tibial or femoral components.

Source page: https://510kreport.com/device/K250980
Methodology: https://510kreport.com/methodology