FDA.reportPublic FDA data

RESTORIS PST

Primary DI
00848486016159
Brand
RESTORIS PST
Company
MAKO SURGICAL CORP.
Model
188605
Catalog number
188605
Device description
Porous Tibial Baseplate
Published
2015-12-11
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
NJDPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133811000RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corp.2014-07-08NJD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486016159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486016159008484860161598484860161590848486016159

GMDN Terms#

Term, Definition table
TermDefinition
Coated unicondylar knee tibia prosthesisA sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a femoral component and an insert, and its implantation may be performed with or without bone cement.

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

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