FDA.reportPublic FDA data

ROSA Partial Knee Software

Primary DI
00887868578939
Brand
ROSA Partial Knee Software
Company
Orthosoft Inc
Model
20-8020-150-01
Published
2026-10-27
Public version status
New
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
K210121000
K232533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210121000ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas2021-04-19OLO
K232533000ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas2023-11-16OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868578939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868578939008878685789398878685789390887868578939

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical navigation radiology softwareA software program intended to display, analyse/process, and possibly acquire images of a limb bone(s), rib(s), the sternum and/or pelvis (excludes craniofacial and spinal), typically acquired via computed tomography (CT) or fluoroscopic x-ray, primarily to assist with the navigation/positioning of surgical instruments, implants, and/or the patient during orthopaedic surgery [computer assisted surgery (CAS)]. It does not incorporate adaptive/dynamic machine learning (ML) models.

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868552113Signature ONE Software Package302.40182026-10-27
00887868578922ROSA® Knee20-8020-130-012026-10-27
00887868581090ROSA® Robotics20-8020-028-002026-10-27
00887868581106ROSA® Robotics20-8020-029-002026-10-27
00889024305533iASSIST20-8011-070-042026-10-27
00889024305557iASSIST20-8011-070-082026-10-27
00889024671270ROSA® Hip20-8060-400-012026-10-27
00887868573040Sesamoid® System20-8000-000-012026-10-26
00887868573057Sesamoid® System20-8000-000-022026-10-26
00887868579608ROSA® Robotics20-8000-010-062026-10-26
00887868579615ROSA® Robotics20-8000-010-172026-10-26
00887868579622ROSA® Robotics20-8000-010-332026-10-26
00887868579639ROSA® Robotics20-8000-010-352026-10-26
00887868579646ROSA® Robotics20-8000-010-362026-10-26
00889024705999Navitracker20-8000-070-052026-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337118985J-Needle Navi WL 120, trocar, 11 GJoimax GmbHOLO2026-10-28
00887868578922ROSA® KneeOrthosoft IncOLO2026-10-27
00887868581090ROSA® RoboticsOrthosoft IncOLO2026-10-27
00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
00889024671270ROSA® HipOrthosoft IncOLO2026-10-27
04056481145323Patient Reference Carbon-Clamp Spine & TraumaBrainlab SEOLO2026-10-27
04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
04056481148225Sterilization Tray Accessories Spine MISBrainlab SEOLO2026-10-27
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26
00887868573040Sesamoid® SystemOrthosoft IncOLO2026-10-26
00887868573057Sesamoid® SystemOrthosoft IncOLO2026-10-26
00887868579608ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579615ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579622ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579639ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579646ROSA® RoboticsOrthosoft IncOLO2026-10-26
00889024705999NavitrackerOrthosoft IncOLO2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-23
04056481146207Spine PlanningBrainlab SEOLO2026-10-23
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