FDA.reportPublic FDA data

PHYSICA POROUS PS

Primary DI
08033390148535
Brand
PHYSICA POROUS PS
Company
LIMACORPORATE SPA
Model
6515.10.550
Catalog number
6515.10.550
Device description
PHYSICA POROUS PS - Femoral Component #5 Cementless Left
Published
2021-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210554000
K243615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210554000Physica systemLima Corporate S.P.A.2021-04-06MBH
K243615000Physica Porous Femoral ComponentsLima Corporate S.P.A.2024-12-18MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390148535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390148535080333901485358033390148535

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
432066322
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033390201858Smart SPACE SHOULDER0023.L1.N330023.L1.N332023-02-18
08033390201872Smart SPACE SHOULDER0023.L2.N330023.L2.N332023-02-18
08033390201896Smart SPACE SHOULDER0023.L3.N330023.L3.N332023-02-18
08033390201919Smart SPACE SHOULDER0023.R1.N330023.R1.N332023-02-18
08033390201933Smart SPACE SHOULDER0023.R2.N330023.R2.N332023-02-18
08033390201957Smart SPACE SHOULDER0023.R3.N330023.R3.N332023-02-18
08033390239509Smart SPACE SHOULDER0023.R4.N330023.R4.N332023-02-18
08033390239516Smart SPACE SHOULDER0023.L4.N330023.L4.N332023-02-18
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017265438EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
08800017265445EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
00192629475007EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475007EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03