FDA.reportPublic FDA data

Mako

Primary DI
00848486016401
Brand
Mako
Company
MAKO SURGICAL CORP.
Model
180732-2
Catalog number
180732-2
Device description
Tibial Bearing Insert
Published
2015-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
NJDPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, 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
NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, 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
K150307000
K150410000
K220930000
K242831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150307000RESTORIS Multicompartmental Knee SystemMako Surgical Corp.2015-03-10NPJ
K150410000RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corporation2015-03-20HRY
K220930000Restoris Multi-Compartmental Knee SystemMako Surgical Corp.2022-06-02HSX
K242831000Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-12-04JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486016401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486016401008484860164018484860164010848486016401

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

Regulatory Flags#

DUNS number
175239677
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
00848486016418Mako180732-3180732-32015-11-04
00848486016432Mako180732-5180732-52015-11-04
00848486016449Mako180733-1180733-12015-11-04
00848486016456Mako180733-2180733-22015-11-04
00848486016463Mako180733-3180733-32015-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056139247712Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247729Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247736Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247743Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247767Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247774Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247781Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247798Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247897Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247903Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247910Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247927Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247934Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139247996Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248009Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248016Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248023Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248030Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248092Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248108Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248115Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248122Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248139Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248191Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248207Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248214Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248221Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248238Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248290Unity Total Knee SystemCORIN LTDOIY2026-10-19
05056139248306Unity Total Knee SystemCORIN LTDOIY2026-10-19