ELEOS™ Limb Salvage System THSMWOS01M

GUDID B278THSMWOS01M0

ELEOS™ TIBIAL HINGE W/OUT ROTATIONAL STOP ONE SIZE

ONKOS SURGICAL, INC.

Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic

• Primary Device ID: B278THSMWOS01M0
• NIH Device Record Key: 51fe93b5-65cb-4ec4-888d-789a224f04a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEOS™ Limb Salvage System
• Version Model Number: THSMWOS01M
• Catalog Number: THSMWOS01M
• Company DUNS: 080254074
• Company Name: ONKOS SURGICAL, 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com
• Phone: +1(844)767-2766
• Email: customerservice@onkossurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B278THSMWOS01M0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161520

FDA Product Code

• KRO: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

Sterilization

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

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

[B278THSMWOS01M0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-18
• Device Publish Date: 2022-02-10

On-Brand Devices [ELEOS™ Limb Salvage System]

• B278TB2205E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 5 80MM M/L
• B278TB2204E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 4 75MM M/L
• B278TB2203E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 3 70MM M/L
• B278TB2202E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 2 65MM M/L
• B278TB2201E01M0: ELEOS™ TIBIAL BASEPLATE, SIZE 1 60MM M/L
• B27800103000210: ELEOS™ INSTRUMENTATION TRAY, 21
• B27800103000220: ELEOS™ INSTRUMENTATION TRAY, 22
• B278RFR004E01M0: ELEOS™ Resurfacing Femur, Size 4, Right
• B278RFR003E01M0: ELEOS™ Resurfacing Femur, Size 3, Right
• B278RFR002E01M0: ELEOS™ Resurfacing Femur, Size 2, Right
• B278RFL004E01M0: ELEOS™ Resurfacing Femur, Size 4, Left
• B278RFL003E01M0: ELEOS™ Resurfacing Femur, Size 3, Left
• B278RFL002E01M0: ELEOS™ Resurfacing Femur, Size 2, Left
• B278TBTSCRW01N0: ELEOS™ Tibial Baseplate Tapered Screw
• B278RFTSCRW01N0: ELEOS™ Resurfacing Femur Tapered Screw
• B278THSMWOS01M0: ELEOS™ TIBIAL HINGE W/OUT ROTATIONAL STOP ONE SIZE
• B278TBTSCRW01M0: ELEOS™ Tibial Baseplate Tapered Screw
• B278RFTSCRW01M0: ELEOS™ Resurfacing Femur Tapered Screw
• B278CB1720003M0: ELEOS Segmental Stem, Cemented, 17mm x 200mm, Bowed, Fluted, 36mm Collar
• B278CB1520003M0: ELEOS Segmental Stem, Cemented, 15mm x 200mm, Bowed, Fluted, 32mm Collar
• B278CB1320003M0: ELEOS Segmental Stem, Cemented, 13mm x 200mm, Bowed, Fluted, 28mm Collar
• B278CB1125503M0: ELEOS Segmental Stem, Cemented, 11mm x 255mm, Bowed, Fluted, 32mm Collar