FDA.reportPublic FDA data

iAssist® Knee System

Primary DI
00889024305298
Brand
iAssist® Knee System
Company
Orthosoft Inc
Model
20-8011-019-00
Catalog number
20-8011-019-00
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122326000
K141601000
K192080000
K213033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122326000SMARTTOOLS KNEE SYSTEMZimmer2012-11-30OLO
K141601000IASSIST KNEE SYSTEMZimmer Cas2014-09-11OLO
K192080000iASSIST Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)2019-11-05OLO
K213033000iASSIST Knee SystemOrthosoft D/B/A Zimmer Cas2022-01-14OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024305298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024305298008890243052988890243052980889024305298

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)336-7846zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00887868552120ROSA®20-8020-158-0020-8020-158-002023-04-10
00887868558146ROSA® Shoulder20-8087-302-00208087302002024-03-06
00887868580963ROSA® Shoulder20-8087-506-00208087506002024-03-06
00887868554391Signature™ Comprehensive®20-8090-009-0120-8090-009-012024-02-09
00887868554407Signature™ Comprehensive®20-8090-009-0220-8090-009-022024-02-09
00887868552205ROSA® Knee20-8020-191-0020-8020-191-002022-10-20
00889024563636Sesamoid ®20-8000-000-1120-8000-000-112021-01-28
00889024304079Trabecular Metal20-8075-004-0220-8075-004-022016-09-12
00889024304307ROSA® Robotics20-8000-010-0620-8000-010-062016-09-07
00889024304406ROSA® Robotics20-8000-010-1720-8000-010-172016-09-07
00889024304413Optical20-8000-010-1820-8000-010-182016-09-12
00889024304567ROSA® Robotics20-8000-010-3320-8000-010-332016-09-12
00889024304871Optical20-8000-020-1320-8000-020-132016-09-12
00889024304895Optical20-8000-020-1520-8000-020-152016-09-12
00889024304956Optical20-8000-020-2120-8000-020-212016-09-12
00889024305397iASSIST20-8011-040-0020-8011-040-002016-09-07
00889024305748Signature ONE20-8070-009-002017-06-13
00889024305762PSI Knee20-8070-010-022017-09-28
00889024486638X-PSI™20-8085-020-0020-8085-020-002018-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
00889024699762ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncOLO2026-06-26
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00889024703186ROSA® ShoulderOrthosoft IncOLO2026-01-27
00889024674790ROSA PIN STABILIZER 60MMOrthosoft IncOLO2025-12-12
00889024674776ROSA POLYAXIAL REFERENCE SIZE 3Orthosoft IncOLO2025-12-11
00889024674783ROSA POLYAXIAL REFERENCE SIZE 6Orthosoft IncOLO2025-12-11
00889024674806ROSA STABILIZER TISSUE DEFLECTOR 60MMOrthosoft IncOLO2025-12-11
00889024687455ROSA® KneeOrthosoft IncOLO2025-11-21
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
00887868557873ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557880ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557897ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557903ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868557910ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558078ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558092ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868558146ROSA® ShoulderOrthosoft IncOLO2024-03-06