FDA.reportPublic FDA data

RESTORIS ESYNTIAL

Primary DI
00848486015657
Brand
RESTORIS ESYNTIAL
Company
MAKO SURGICAL CORP.
Model
180746-6
Catalog number
180746-6
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
00848486015657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486015657008484860156578484860156570848486015657

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

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
07613327594829Common Shoulder Driver1906601906602026-05-21
07613327595543Mako2906512906512026-05-21
07613327579888N/A7000015775787000015775782024-08-07
07613327595505Mako Glenoid RetractorSmall1906652026-01-08
07613327625868INSTRUMENT7000021128907000021128902024-10-04
07613327624304NA2299992299992024-09-18
07613327395280NA2199992199992020-12-15
00848486021702RIO2038662038662016-09-24
00848486022211NA2071102071102016-09-24
00848486023249NA2099272099272016-09-24
00848486030407NA2099992099992016-09-24
07613327627725MakoShoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.17000028873152026-03-10
07613327683653Shoulder 1.5 Installation Disk7000043787467000043787462026-03-03
00848486000349RESTORIS180320-2180320-22015-09-24
00848486000356RESTORIS180320-1180320-12015-09-24
00848486000370RESTORIS180320-4180320-42015-09-24
00848486000387RESTORIS180320-5180320-52015-09-24
00848486000394RESTORIS180320-6180320-62015-09-24
00848486000400RESTORIS1804021804022015-09-24
00848486000417RESTORIS1804031804032015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014587ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014594ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.HRY2015-09-24
07613327015508TriathlonHowmedica Osteonics Corp.HRY2015-09-24
07613327015508TriathlonHowmedica Osteonics Corp.HSX2015-09-24