PointCloud Knee Instruments

GUDID TKRR000128LL0

UNIKO PointCloud Knee Instrument Kit

Unik Orthopedics Inc.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: TKRR000128LL0
• NIH Device Record Key: b93855ec-10b7-4f6e-a8e5-d9cacf90d7f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PointCloud Knee Instruments
• Version Model Number: UKI0201-R
• Company DUNS: 118205691
• Company Name: Unik Orthopedics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	TKRR000128LL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240327

FDA Product Code

• MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

[TKRR000128LL0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-17
• Device Publish Date: 2025-03-07

On-Brand Devices [PointCloud Knee Instruments]

• TKRR000111L00: UKI0201-R
• TKRR0001111K0: UKI0201-R
• TKRR000110B50: UKI0201-R
• TKRL000115KK0: UKI0201-L
• TKRL000113D70: UKI0201-L
• TKRL000112II0: UKI0201-L
• TKRL0001124I0: UKI0201-L
• TKRR00014446: UNIKO PointCloud Knee Instrument Kit
• TKRR000143L60: UNIKO PointCloud Knee Instrument Kit
• TKRR000141F30: UNIKO PointCloud Knee Instrument Kit
• TKRR0001418L0: UNIKO PointCloud Knee Instrument Kit
• TKRR00013L0L0: UNIKO PointCloud Knee Instrument Kit
• TKRR00013K7D0: UNIKO PointCloud Knee Instrument Kit
• TKRR00013DII0: UNIKO PointCloud Knee Instrument Kit
• TKRR00013D450: UNIKO PointCloud Knee Instrument Kit
• TKRR00013BIL0: UNIKO PointCloud Knee Instrument Kit
• TKRR00013B4I0: UNIKO PointCloud Knee Instrument Kit
• TKRR000139580: UNIKO PointCloud Knee Instrument Kit
• TKRR000138FI0: UNIKO PointCloud Knee Instrument Kit
• TKRR0001382I0: UNIKO PointCloud Knee Instrument Kit
• TKRR000137650: UNIKO PointCloud Knee Instrument Kit
• TKRR0001369K0: UNIKO PointCloud Knee Instrument Kit
• TKRR000136380: UNIKO PointCloud Knee Instrument Kit
• TKRR000135D40: UNIKO PointCloud Knee Instrument Kit
• TKRR0001350I0: UNIKO PointCloud Knee Instrument Kit
• TKRR000134II0: UNIKO PointCloud Knee Instrument Kit
• TKRR000134420: UNIKO PointCloud Knee Instrument Kit
• TKRR0001337F0: UNIKO PointCloud Knee Instrument Kit
• TKRR000132B60: UNIKO PointCloud Knee Instrument Kit
• TKRR000131LD0: UNIKO PointCloud Knee Instrument Kit
• TKRR0001305F0: UNIKO PointCloud Knee Instrument Kit
• TKRR00012IL50: UNIKO PointCloud Knee Instrument Kit
• TKRR00012F2F0: UNIKO PointCloud Knee Instrument Kit
• TKRR00012D3L0: UNIKO PointCloud Knee Instrument Kit
• TKRR000129B80: UNIKO PointCloud Knee Instrument Kit
• TKRR000129530: UNIKO PointCloud Knee Instrument Kit
• TKRR000128LL0: UNIKO PointCloud Knee Instrument Kit
• TKRR000127K50: UNIKO PointCloud Knee Instrument Kit
• TKRR0001269I0: UNIKO PointCloud Knee Instrument Kit
• TKRR0001256K0: UNIKO PointCloud Knee Instrument Kit
• TKRR0001250L0: UNIKO PointCloud Knee Instrument Kit
• TKRR0001243F0: UNIKO PointCloud Knee Instrument Kit
• TKRR000123770: UNIKO PointCloud Knee Instrument Kit
• TKRR000120K30: UNIKO PointCloud Knee Instrument Kit
• TKRR000120590: UNIKO PointCloud Knee Instrument Kit
• TKRR00011K6F0: UNIKO PointCloud Knee Instrument Kit
• TKRR00011FF00: UNIKO PointCloud Knee Instrument Kit
• TKRR00011F940: UNIKO PointCloud Knee Instrument Kit
• TKRR00011DI30: UNIKO PointCloud Knee Instrument Kit
• TKRR0001188B0: UNIKO PointCloud Knee Instrument Kit