FDA.reportPublic FDA data

RESTORIS ESYNTIAL

Primary DI
00848486015282
Brand
RESTORIS ESYNTIAL
Company
MAKO SURGICAL CORP.
Model
180742-5
Catalog number
180742-5
Device description
MCK Onlay Tibial Insert
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
NPJPROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133039000RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMMako Surgical Corporation2013-12-10NPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486015282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486015282008484860152828484860152820848486015282

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175239677
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848486002534VIZADISC1071301071302016-09-24
00848486001414VIZADISC1071201071202016-09-24
07613327626971Mako1.01906872024-11-15
00848486001346NA1116501116502016-09-24
00848486001353NA1116511116512016-09-24
00848486001360NA1116521116522016-09-24
00848486002978NA1162301162302016-09-24
00848486002985NA1162401162402016-09-24
00848486017316NA1116531116532016-09-24
00848486017323NA1116551116552016-09-24
00848486029487NA1116441116442016-09-24
00848486029494NA1116451116452016-09-24
07613327579840N/A7000015775847000015775842025-09-08
07613327579888N/A7000015775787000015775782024-08-07
07613327630602Mako7000029506277000029506272026-08-25
00848486016401Mako180732-2180732-22015-11-04
00848486016418Mako180732-3180732-32015-11-04
00848486016432Mako180732-5180732-52015-11-04
00848486016449Mako180733-1180733-12015-11-04
00848486016456Mako180733-2180733-22015-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247750Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247804Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247811Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247828Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247835Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247941Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247958Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247965Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247972Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139247989Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248047Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248054Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248061Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248078Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248085Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248146Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248153Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248160Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248177Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248184Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139248597Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249013Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249020Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249037Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249044Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249303Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249310Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249327Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249334Unity Total Knee SystemCORIN LTDOIY2026-10-23
05056139249341Unity Total Knee SystemCORIN LTDOIY2026-10-23