Cleared Traditional

K210554 - Physica system

K210554 is the FDA 510(k) clearance for Physica system by Lima Corporate S.P.A.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K210554 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
40d
Days
Class 2
Risk

K210554 is an FDA 510(k) clearance for the Physica system. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Udine, IT). The FDA issued a Cleared decision on April 6, 2021 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lima Corporate S.P.A. devices

Submission Details

510(k) Number K210554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2021
Decision Date April 06, 2021
Days to Decision 40 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 122d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Lima U.S.A., Inc.
Lacey Harbour

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 123
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K210554.
Porous Patella and Porous Tibia Baseplate
K211221 · Smith & Nephew, Inc. · Oct 2021
Symmetric Total Knee System
K203779 · Signal Medical Corporation · Jun 2021
LEGION CR Porous Plus HA Femoral Components
K211246 · Smith & Nephew, Inc. · May 2021
EMPOWR Porous Femur with HAnano SurfaceTM
K210308 · Encore Medical, L.P. · Mar 2021
LEGION Porous CR Narrow Femoral Components
K210566 · Smith & Nephew, Inc. · Mar 2021
Physica system
K201084 · Lima Corporate S.P.A. · Dec 2020