FDA.reportPublic FDA data

Apollo Knee

Primary DI
05056139245787
Brand
Apollo Knee
Company
CORIN LTD
Model
TKR.BB.1101
Device description
Pre-Resection BalanceBot Paddles, Right A
Published
2025-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K231172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231172000ApolloKneeCorin U.S.A. Limited2023-07-26OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056139245787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056139245787050561392457875056139245787

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical arm systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401285649231customersupport@coringroup.com

Regulatory Flags#

DUNS number
295437313
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056139247712Unity Total Knee System11261092026-10-19
05056139247729Unity Total Knee System11262092026-10-19
05056139247736Unity Total Knee System112640911264092026-10-19
05056139247743Unity Total Knee System112630911263092026-10-19
05056139247767Unity Total Knee System112680911268092026-10-19
05056139247774Unity Total Knee System112670911267092026-10-19
05056139247781Unity Total Knee System112660911266092026-10-19
05056139247798Unity Total Knee System112650911265092026-10-19
05056139247897Unity Total Knee System11262102026-10-19
05056139247903Unity Total Knee System11262112026-10-19
05056139247910Unity Total Knee System11262122026-10-19
05056139247927Unity Total Knee System112621411262142026-10-19
05056139247934Unity Total Knee System112621611262162026-10-19
05056139247996Unity Total Knee System112631011263102026-10-19
05056139248009Unity Total Knee System112631111263112026-10-19
05056139248016Unity Total Knee System112631211263122026-10-19
05056139248023Unity Total Knee System112631411263142026-10-19
05056139248030Unity Total Knee System112631611263162026-10-19
05056139248092Unity Total Knee System112641011264102026-10-19
05056139248108Unity Total Knee System112641111264112026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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