FDA.reportPublic FDA data

Nexgen

Primary DI
00889024305694
Brand
Nexgen
Company
Orthosoft Inc
Model
20-8070-006-02
Catalog number
20-8070-006-02
Published
2016-09-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131409000CAS PSI KNEE SYSTEMOrthosoft, Inc.2013-09-13JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024305694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024305694008890243056948890243056940889024305694

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming armA surgical jig-like device designed as a precision guide for the pre-drilling of orthopaedic screw holes into bone and for guiding an orthopaedic instrument into an implanted device, typically to treat long bones (e.g., femur, humerus, and tibia). It typically consists of two parts in one-piece or modular configurations: 1) an insertion guide in which the correctly angled/placed guide holes are situated; and 2) an insertion handle which will attach to the bone or implant. Drill guides or other drilling/tapping devices will be fed through the insertion guide at the precise intended angle, and it may have adaptations for providing magnetic alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)-348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00889024211605NA302.4002302.40022016-09-14
00889024211636iASSIST302.4001302.40012016-09-14
00889024305083Sesamoid20-8000-070-3520-8000-070-352016-09-12
00889024305090Sesamoid20-8000-070-3620-8000-070-362016-09-12
00889024305106Sesamoid20-8000-070-3720-8000-070-372016-09-12
00889024305113Sesamoid20-8000-070-3820-8000-070-382016-09-12
00889024305120Sesamoid20-8000-070-3920-8000-070-392016-09-12
00889024305205Sesamoid20-8000-070-6420-8000-070-642016-09-12
00889024478954Sesamoid Plasty V2 Stand20-8000-070-8020-8000-070-802016-12-21
00889024478961Camera Kit20-8000-070-9920-8000-070-992016-12-21
00889024478978Sesamoid Plasty V2 Computer Kit20-8000-070-7720-8000-070-772016-12-21
00889024485518AC power cord North America20-8000-070-7120-8000-070-712016-12-21
00889024488502Sesamoid Plasty V2 HDMI Cable 30'20-8000-071-242017-04-10
00889024492752NA20-8000-070-212017-09-12
00889024492769NA20-8000-070-462017-09-12
00889024511026ROSA® Recon Platform20-8020-100-0120-8020-100-012019-03-06
00889024511170ROSA® Recon20-8020-110-0120-8020-110-012019-03-06
00889024511323ROSA® KNEE OPTICAL UNIT20-8020-120-0120-8020-120-012019-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215158828World Knee MC Poly Insert - Size 8 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158835World Knee MC Poly Insert - Size 8 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158842World Knee MC Poly Insert - Size 8 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158859World Knee MC Poly Insert - Size 8 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158866World Knee MC Poly Insert - Size 8 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158873World Knee MC Poly Insert - Size 8 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158880World Knee MC Poly Insert - Size 8 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158897World Knee MC Poly Insert - Size 8 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158903World Knee MC Poly Insert - Size 8 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158910World Knee MC Poly Insert - Size 8 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158927World Knee MC Poly Insert - Size 8 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158934World Knee MC Poly Insert - Size 8 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158941World Knee MC Poly Insert - Size 8 - 13mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158958World Knee MC Poly Insert - Size 8 - 14mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158965World Knee MC Poly Insert - Size 8 - 15mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158972World Knee MC Poly Insert - Size 8 - 16mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158989World Knee MC Poly Insert - Size 8 - 17mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158996World Knee MC Poly Insert - Size 8 - 18mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160265World Knee MC Vit-E Poly Insert - Size 7 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160272World Knee MC Vit-E Poly Insert - Size 7 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160289World Knee MC Vit-E Poly Insert - Size 7 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160296World Knee MC Vit-E Poly Insert - Size 7 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160302World Knee MC Vit-E Poly Insert - Size 7 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160319World Knee MC Vit-E Poly Insert - Size 7 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160326World Knee MC Vit-E Poly Insert - Size 7 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160333World Knee MC Vit-E Poly Insert - Size 7 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160340World Knee MC Vit-E Poly Insert - Size 7 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160357World Knee MC Vit-E Poly Insert - Size 7 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160364World Knee MC Vit-E Poly Insert - Size 7 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160371World Knee MC Vit-E Poly Insert - Size 7 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09