FDA.reportPublic FDA data

PointCloud Knee Instruments

Primary DI
TKRL000185L90
Brand
PointCloud Knee Instruments
Company
Unik Orthopedics Inc.
Model
UKI0201-L
Device description
UNIKO PointCloud Knee Instrument Kit
Published
2025-10-04
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
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240327000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240327000UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.2024-06-27JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TKRL000185L90PrimaryHIBCC0

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
00840097536705Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536705Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536712Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536712Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536781Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536781Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536798Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536798Identity CR KARestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.JWH2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.MBH2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25