FDA.reportPublic FDA data

Mako

Primary DI
00848486016449
Brand
Mako
Company
MAKO SURGICAL CORP.
Model
180733-1
Catalog number
180733-1
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
00848486016449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486016449008484860164498484860164490848486016449

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
00848486016401Mako180732-2180732-22015-11-04
00848486016418Mako180732-3180732-32015-11-04
00848486016432Mako180732-5180732-52015-11-04
00848486016456Mako180733-2180733-22015-11-04
00848486016463Mako180733-3180733-32015-11-04
00848486016487Mako180733-5180733-52015-11-04
00848486016494Mako180734-1180734-12015-11-04
00848486016500Mako180734-2180734-22015-11-04
00848486016517Mako180734-3180734-32015-11-04
00848486016531Mako180734-5180734-52015-11-04
00848486016548Mako180735-1180735-12015-11-04
00848486016555Mako180735-2180735-22015-11-04
00848486016562Mako180735-3180735-32015-11-04
00848486016586Mako180735-5180735-52015-11-04
00848486016593Mako180736-1180736-12015-11-04
00848486016609Mako180736-2180736-22015-11-04
00848486016616Mako180736-3180736-32015-11-04
00848486016630Mako180736-5180736-52015-11-04
00848486016647Mako180737-1180737-12015-11-04
00848486016654Mako180737-2180737-22015-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982533663ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533670ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533687ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533694ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533700ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533717ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533724ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533731ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533748ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533861ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533878ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533885ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533892ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533908ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533915ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533922ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533939ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982533946ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677428ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677435ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677442ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00193982677459ACTIFY 3DGLOBUS MEDICAL, INC.OIY2026-08-14
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OIY2026-07-31
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17