# K152008: Physica PS Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Oct 29, 2015 after 100 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K951987 (1995). 81 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 89 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 4.
- K151266: Physica CR Knee System, Lima Corporate S.P.A. (2015). Cleared while this submission was under review Summary page 5.
- K121879: Vega Knee System, Aesculap Implant Systems (2012) Summary page 5.
- K042515: Smith & Nephew, Inc. High Performance Knee, Smith & Nephew, Inc. (2005) Summary page 5.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 5.

## Most influential descendants
- K193284: Physica LMC Knee System (2020), 6 descendants of its own
- K201084: Physica system (2020), 5 descendants of its own
- 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

## Indications for 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. Physica knee system is intended for cemented fixation.

Source page: https://510kreport.com/device/K152008
Methodology: https://510kreport.com/methodology
