FDA.report

Responsive Orthopedics Total Knee Arthroplasty System

Primary DI
00841973100416
Brand
Responsive Orthopedics Total Knee Arthroplasty System
Company
RESPONSIVE ORTHOPEDICS, LLC
Model
90-SRK-110220
Device description
Poly Insert CR, Size 2, 20mm
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841973100416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841973100416008419731004168419731004160841973100416

GMDN Terms

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

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 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

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00889024706811Biomet®Biomet Orthopedics, LLCJWH2026-03-12
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