FDA.reportPublic FDA data

Responsive Orthopedics Total Knee Arthroplasty System

Primary DI
00841973106135
Brand
Responsive Orthopedics Total Knee Arthroplasty System
Company
RESPONSIVE ORTHOPEDICS, LLC
Model
90-SRK-201300
Catalog number
90-SRK-201300
Device description
IMPACTOR 90-SRK-201300 TIBIAL TRAY
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
00841973106135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841973106135008419731061358419731061350841973106135

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080074787
Device count
1
Premarket exempt
true
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
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
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
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.JWH2026-07-31
03701089509695AMPLITUDEAMPLITUDE SASJWH2026-07-31
03701089517492TRAXAMPLITUDE SASJWH2026-07-29
03701089517508TRAXAMPLITUDE SASJWH2026-07-29
03701089517515TRAXAMPLITUDE SASJWH2026-07-29
03701089517522TRAXAMPLITUDE SASJWH2026-07-29
03701089517539TRAXAMPLITUDE SASJWH2026-07-29
03701089517546TRAXAMPLITUDE SASJWH2026-07-29
03701089517553TRAXAMPLITUDE SASJWH2026-07-29
03701089517560TRAXAMPLITUDE SASJWH2026-07-29
03701089517577TRAXAMPLITUDE SASJWH2026-07-29
03701089517584TRAXAMPLITUDE SASJWH2026-07-29
03701089517591TRAXAMPLITUDE SASJWH2026-07-29
03701089517607TRAXAMPLITUDE SASJWH2026-07-29
03701089517614TRAXAMPLITUDE SASJWH2026-07-29
03701089517621TRAXAMPLITUDE SASJWH2026-07-29
03701089517638TRAXAMPLITUDE SASJWH2026-07-29
03701089517645TRAXAMPLITUDE SASJWH2026-07-29
03701089517652TRAXAMPLITUDE SASJWH2026-07-29
03701089517669TRAXAMPLITUDE SASJWH2026-07-29
03701089518390TRAXAMPLITUDE SASJWH2026-07-29
03701089518406TRAXAMPLITUDE SASJWH2026-07-29
03701089518413TRAXAMPLITUDE SASJWH2026-07-29
03701089518420TRAXAMPLITUDE SASJWH2026-07-29
03701089518437TRAXAMPLITUDE SASJWH2026-07-29
03701089518444TRAXAMPLITUDE SASJWH2026-07-29