FDA.reportPublic FDA data

Responsive Orthopedics Total Knee Arthroplasty System

Primary DI
00841973106166
Brand
Responsive Orthopedics Total Knee Arthroplasty System
Company
RESPONSIVE ORTHOPEDICS, LLC
Model
90-SRK-100010
Catalog number
90-SRK-100010
Device description
TOOL 90-SRK-100010 POLY REMOVAL
Published
2016-09-03
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
00841973106166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841973106166008419731061668419731061660841973106166

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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
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
00841973106234Responsive Orthopedics Total Knee Arthroplasty System90-SRK-35111190-SRK-3511112016-09-03

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