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Physica system

by Lima Corporate S.P.A. 510(k)

Active United States

510(k) K213381

Overview

The Physica system is a complete system for primary total knee replacement, offering four different configurations: Kinematic Retaining (KR), Posterior Stabilized (PS), Lima Medial Congruent (LMC), and Cruciate Retaining (CR). It is designed to restore native knee kinematics and optimize function.

The device is manufactured by Lima Corporate S.P.A. and is supplied as a Class 2 Orthopedic device with product code JWH. It has received FDA 510(k) clearance through the Traditional pathway after a 235-day FDA review. The device is intended for use in total knee replacement procedures.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK213381 Date17 Dec 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0524-2024 FDA Class II initiated 27 Oct 2023

    Due to incorrect product labeling

Specification

510(k)

510(k) Number
FDA Product Code
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Lima Corporate S.P.A.

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Questions

  • What is the Physica system used for?

    The Physica system is a complete system designed for primary total knee replacement procedures. It offers four different configurations: Kinematic Retaining (KR), Posterior Stabilized (PS), Lima Medial Congruent (LMC), and Cruciate Retaining (CR), all intended to restore native knee kinematics and optimize function.

  • How is the Physica system supplied and what is its regulatory status?

    The Physica system is supplied as a Class 2 Orthopedic device with product code JWH. It has received FDA 510(k) clearance through the Traditional pathway after a 235-day FDA review, with a decision date of December 17, 2021.

  • What are the different configurations available with the Physica system?

    The Physica system offers four different configurations for total knee replacement: Kinematic Retaining (KR), Posterior Stabilized (PS), Lima Medial Congruent (LMC), and Cruciate Retaining (CR). Each configuration is designed to address different patient needs and surgical approaches while restoring native knee kinematics.

  • Who manufactures the Physica system and where is it manufactured?

    The Physica system is manufactured by Lima Corporate S.P.A., located in Villanova Di San Daniele Del Friuli, Italy. The company's address is Via Nazionale 52, with postal code 33038.