FDA.reportPublic FDA data

Responsive Orthopedics Total Knee Arthroplasty System

Primary DI
00841973108306
Brand
Responsive Orthopedics Total Knee Arthroplasty System
Company
RESPONSIVE ORTHOPEDICS, LLC
Model
90-SRK-460014
Catalog number
90-SRK-460014
Device description
PUCK 90-SRK-460014 PATELLA - OVAL 41
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841973108306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841973108306008419731083068419731083060841973108306

GMDN Terms#

Term, Definition table
TermDefinition
Patella prosthesis trialA copy of a final patella 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, and to check that patellar ligament balancing is correct. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080074787
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841973105992Responsive Orthopedics Total Knee Arthroplasty System90-SRK-30041090-SRK-3004102016-09-01
00841973106005Responsive Orthopedics Total Knee Arthroplasty System90-SRK-30042090-SRK-3004202016-09-01
00841973106135Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20130090-SRK-2013002016-09-02
00841973106159Responsive Orthopedics Total Knee Arthroplasty System90-SRK-10000090-SRK-1000002016-09-02
00841973105985Responsive Orthopedics Total Knee Arthroplasty System90-SRK-30040090-SRK-3004002016-09-01
00841973106142Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20131090-SRK-2013102016-09-02
00841973106166Responsive Orthopedics Total Knee Arthroplasty System90-SRK-10001090-SRK-1000102016-09-03
00841973108368Responsive Orthopedics Total Knee Arthroplasty System90-SRK-10005090-SRK-1000502016-09-01
00841973108375Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001190-SRK-8000112016-09-14
00841973108382Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001290-SRK-8000122016-09-14
00841973108399Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001390-SRK-8000132016-09-14
00841973108405Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001490-SRK-8000142016-09-14
00841973108412Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80001590-SRK-8000152016-09-15
00841973108429Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80002090-SRK-8000202016-09-15
00841973108436Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80003090-SRK-8000302016-09-15
00841973108443Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80003190-SRK-8000312016-09-15
00841973108450Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80003390-SRK-8000332016-09-15
00841973108467Responsive Orthopedics Total Knee Arthroplasty System90-SRK-80004090-SRK-8000402016-09-15
00841973106111Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20122190-SRK-2012212016-09-02
00841973106128Responsive Orthopedics Total Knee Arthroplasty System90-SRK-20122290-SRK-2012222016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556923023NASmith & Nephew, Inc.JWH2026-07-16
08800017262178EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262185EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262192EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262208EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262215EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262222EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262239EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262246EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262253EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262260EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262277EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262284EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262291EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262307EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262314EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262321EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262338EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262345EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262352EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262369EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262376EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262383EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262390EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262406EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262413EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262420EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262437EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262444EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10
08800017262451EXULT Knee Replacement SystemCorentec Co., LtdJWH2020-01-10