FDA.reportPublic FDA data

Responsive Orthopedics Total Knee Arthroplasty System

Primary DI
00841973101512
Brand
Responsive Orthopedics Total Knee Arthroplasty System
Company
RESPONSIVE ORTHOPEDICS, LLC
Model
90-SRK-141212
Device description
Poly Insert MPCS, Size 2R, 12mm
Published
2016-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
00841973101512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841973101512008419731015128419731015120841973101512

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080074787
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841973100003Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3121002016-03-04
00841973100010Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3111002016-03-04
00841973100027Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3122002016-03-04
00841973100034Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3112002016-03-04
00841973100041Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3123002016-03-04
00841973100058Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3113002016-03-04
00841973100065Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3124002016-03-04
00841973100072Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3114002016-03-04
00841973100089Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3125002016-03-04
00841973100096Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3115002016-03-04
00841973100102Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3126002016-03-04
00841973100119Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3116002016-03-04
00841973100126Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3321002016-03-04
00841973100133Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3311002016-03-04
00841973100140Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3322002016-03-04
00841973100157Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3312002016-03-04
00841973100164Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3323002016-03-04
00841973100171Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3313002016-03-04
00841973100188Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3324002016-03-04
00841973100195Responsive Orthopedics Total Knee Arthroplasty System90-SRK-3314002016-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024706774Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706781Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706798Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706804Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706811Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00843575127143MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127150MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127167MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127174MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127181MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127198MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127204MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127211MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127228MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127235MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127242MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127259MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127266MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127273MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127280MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127297MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127303MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127310MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127327MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127334MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127341MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127358MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127365MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127372MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127389MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06