FDA.reportPublic FDA data

ROSA® Recon

Primary DI
00889024511170
Brand
ROSA® Recon
Company
Orthosoft Inc
Model
20-8020-110-01
Catalog number
20-8020-110-01
Device description
ROSA Recon Robotic Unit 110V
Published
2019-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, image processing, radiological
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182964000
K210121000
K210998000
K213708000
K221928000
K230180000
K230243000
K231162000
K232533000
K233199000
K242864000
K251314000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182964000ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)2019-01-24OLO
K210121000ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas2021-04-19OLO
K210998000ROSA Hip SystemOrthosoft D/B/A Zimmer Cas2021-08-17LLZ
K213708000ROSA® Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)2022-04-22OLO
K221928000ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas2022-10-04OLO
K230180000Rosa Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)2023-02-22OLO
K230243000ROSA® Knee SystemOrthosoft D/B/A Zimmer Cas2023-03-29OLO
K231162000ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas)2023-05-23LLZ
K232533000ROSA Partial Knee SystemOrthosoft D/B/A Zimmer Cas2023-11-16OLO
K233199000ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)2024-02-21OLO
K242864000ROSA® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS2024-10-18OLO
K251314000Rosa® Knee SystemOrthosoft Inc. (d/b/a) Zimmer CAS2025-11-13OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024511170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024511170008890245111708890245111700889024511170

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical telemanipulation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

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
false
Serial number
true
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
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

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Primary DI, Brand, Company table
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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
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00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
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05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
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