Physica LMC Knee System— 510(k) K211938

Name: FDA 510(k) clearance K211938
Creator: U.S. Food and Drug Administration
Published: 2021-07-13

Substantially Equivalent

Limacorporate

FDA 510(k) clearance K211938 for Physica LMC Knee System, Substantially Equivalent on 2021-07-13. Applicant: Limacorporate. Device class: 2.

Clearance details

Applicant: Limacorporate
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2021-06-23
Decision date: 2021-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Villanova Di San Daniele Del Friuli, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K261563 — Freedom Total Knee System (E-Poly Tibial Liners)2026-08-07
K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
K261734 — Klassic Infection Spacer System2026-07-23
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K261032 — NovoKnee (SteriKnee)2026-04-27

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K213785 — SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid2022-05-13
K190911 — Physica KR Liner and SMR Reverse Humeral Liner2019-11-26

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.