FDA.reportPublic FDA data

RESTORIS

Primary DI
00848486003685
Brand
RESTORIS
Company
MAKO SURGICAL CORP.
Model
170607
Catalog number
170607
Device description
MCK BASEPLATE TRIAL (SIZE 7 LM/RL)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082172000
K090763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082172000MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEMMako Surgical Corporation2008-11-28HSX
K090763000RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical Corporation2009-06-17NPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486003685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486003685008484860036858484860036850848486003685

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trialA copy of a final tibia prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
175239677
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327623260Mako7000026060217000026060212026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
07613154557431INSTRUMENTHowmedica Osteonics Corp.HSX2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014549ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.KRR2015-09-24
07613327014556ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.NPJ2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327014570ScorpioHowmedica Osteonics Corp.HSX2015-09-24
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.NPJ2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HSX2015-09-24
07613327014600ScorpioHowmedica Osteonics Corp.HRY2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.HSX2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015478TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.HRY2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.NPJ2015-09-24
07613327015492TriathlonHowmedica Osteonics Corp.KRR2015-09-24
07613327015508TriathlonHowmedica Osteonics Corp.HRY2015-09-24