FDA.reportPublic FDA data

PointCloud

Primary DI
TKRL0000FD355
Brand
PointCloud
Company
Unik Orthopedics Inc.
Model
UKI0101-L
Device description
UNIKO PointCloud™ Knee Instrument Kit Left
Published
2022-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193312000UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.2020-08-12MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TKRL0000FD355PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total knee prosthesis implantation guide-instrument kitA collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118205691
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
TKRL000173910PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001971B0PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001B33I0PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001B7250PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001B9L20PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001BK980PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001BLF60PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D0L90PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D1B10PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D2DB0PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D3410PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D46I0PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D4KF0PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D5990PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D6KI0PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001D8540PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001DBD90PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001DDKK0PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001DFK60PointCloud Knee InstrumentsUKI0201-L2026-05-05
TKRL0001DIID0PointCloud Knee InstrumentsUKI0201-L2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629298675ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298682ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298699ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298705ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298712ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298729ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298736ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298743ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298750ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298767ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298774ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298781ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298798ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298804ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298811ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298828ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298835ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298842ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298859ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298866ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298873ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298880ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298897ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298903ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298910ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298927ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298934ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298941ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298958ProphecyMicroport Orthopedics Inc.MBH2020-09-25
00192629298965ProphecyMicroport Orthopedics Inc.MBH2020-09-25