FDA.reportPublic FDA data

LOSPA Knee System

Primary DI
08806373878008
Brand
LOSPA Knee System
Company
Corentec Co., Ltd
Model
KB.SFT.0111
Device description
MODULAR FEMORAL COMPONENT TRIAL-PS-RIGHT-11
Published
2018-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160157000LOSPA Modular Knee SystemCorentec Co., Ltd.2016-12-01JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806373878008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806373878008088063738780088806373878008

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trial, reusableA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+820415857114hckoh@corentec.com

Regulatory Flags#

DUNS number
688739895
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017271088BENCOXHA.02F.00012026-05-06
08800017261294EXULT Knee Replacement SystemK3.IAN.4266-09T2020-01-10
08800017261300EXULT Knee Replacement SystemK3.IAN.4266-10T2020-01-10
08800017261317EXULT Knee Replacement SystemK3.IAN.4266-11T2020-01-10
08800017261324EXULT Knee Replacement SystemK3.IAN.4266-12T2020-01-10
08800017261331EXULT Knee Replacement SystemK3.IAN.4266-13T2020-01-10
08800017261348EXULT Knee Replacement SystemK3.IAN.4266-14T2020-01-10
08800017261355EXULT Knee Replacement SystemK3.IAN.4266-16T2020-01-10
08800017261362EXULT Knee Replacement SystemK3.IAN.4266-18T2020-01-10
08800017261379EXULT Knee Replacement SystemK3.IAN.4469-09T2020-01-10
08800017261386EXULT Knee Replacement SystemK3.IAN.4469-10T2020-01-10
08800017261393EXULT Knee Replacement SystemK3.IAN.4469-11T2020-01-10
08800017261409EXULT Knee Replacement SystemK3.IAN.4469-12T2020-01-10
08800017261416EXULT Knee Replacement SystemK3.IAN.4469-13T2020-01-10
08800017261423EXULT Knee Replacement SystemK3.IAN.4469-14T2020-01-10
08800017261430EXULT Knee Replacement SystemK3.IAN.4469-16T2020-01-10
08800017261447EXULT Knee Replacement SystemK3.IAN.4469-18T2020-01-10
08800017261454EXULT Knee Replacement SystemK3.IAN.4572-09T2020-01-10
08800017261461EXULT Knee Replacement SystemK3.IAN.4572-10T2020-01-10
08800017261478EXULT Knee Replacement SystemK3.IAN.4572-11T2020-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843575106445MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106452MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106469MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106476MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106483MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106490MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106506MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106513MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106520MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106537MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106544MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106551MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106568MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106575MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106582MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575106599MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107619MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107626MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107633MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107640MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107657MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107664MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107671MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107688MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107695MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107701MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107718MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107725MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107732MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29
00843575107749MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-05-29