JTS EXTENDIBLE DISTAL FEMORAL IMPLANT IMTRRHP-STD

GUDID B278IMTRRHPSTD0

Rotating Hinge Polyethylene Reamer: Standard

ONKOS SURGICAL, INC.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: B278IMTRRHPSTD0
• NIH Device Record Key: 81df7884-f2b9-4952-a940-47f63ae81abc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
• Version Model Number: imtrrhp/Std
• Catalog Number: IMTRRHP-STD
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	05060296233860 [Previous]
HIBCC	B278IMTRRHPSTD0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133152

FDA Product Code

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

Sterilization

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

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

[B278IMTRRHPSTD0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

On-Brand Devices [JTS EXTENDIBLE DISTAL FEMORAL IMPLANT]

• B278TMKTPSTD5R0: Trial Tibial Plateau Plate: 5mm Standard
• B278TMKTPSTD20R0: Trial Tibial Plateau Plate: 20mm Standard
• B278TMKTPSTD15R0: Trial Tibial Plateau Plate: 15mm Standard
• B278TMKTPSTD10R0: Trial Tibial Plateau Plate: 10mm Standard
• B278TMKTPSM5R0: Trial Tibial Plateau Plate: 5mm Small
• B278TMKTPSM20R0: Trial Tibial Plateau Plate: 20mm Small
• B278TMKTPSM15R0: Trial Tibial Plateau Plate: 15mm Small
• B278TMKTPSM10R0: Trial Tibial Plateau Plate: 10mm Small
• B278TMKTPEXSM200: Trial Tibial Plateau Plate: 20mm Extra-Small
• B278TMKTPEXSM150: Trial Tibial Plateau Plate: 15mm Extra-Small
• B278TMKTPEXSM100: Trial Tibial Plateau Plate: 10mm Extra-Small
• B278SMMLTBC000: Tibial Rotating Hinge Metal Cased Bearing XSM
• B278SMMLTB020: Tibial Rotating Hinge Metal Cased Bearing STD
• B278SMMLTB010: Tibial Rotating Hinge Metal Cased Bearing SM
• B278SMLTBC020: Tibial Rotating Hinge Poly Cased Bearing STD
• B278SMLTBC010: Tibial Rotating Hinge Poly Cased Bearing SM
• B278SMLTBC000: Tibial Rotating Hinge Poly Cased Bearing XSM
• B278SMBPR020: Bumper Pad STD
• B278MKTPSTD50: Tibial Plateau Plate STD 5mm
• B278MKTPSTD200: Tibial Plateau Plate STD 20mm
• B278MKTPSTD150: Tibial Plateau Plate STD 15mm
• B278MKTPSTD100: Tibial Plateau Plate STD 10mm
• B278MKTPSM50: Tibial Plateau Plate SM 5mm
• B278MKTPSM200: Tibial Plateau Plate SM 20mm
• B278MKTPSM150: Tibial Plateau Plate SM 15mm
• B278MKTPSM100: Tibial Plateau Plate SM 10mm
• B278JTSDFRSTD0: JTS Distal Femur Right STD
• B278JTSDFLXSM0: JTS Distal Femur Left XSM
• B278IMTRRHPSTD0: Rotating Hinge Polyethylene Reamer: Standard
• B278IMTRRHPSM0: Rotating Hinge Polyethylene Reamer: Small
• B278IMTRRHPEXSM0: Rotating Hinge Polyethylene Reamer: Extra-Small
• B278IMTRRHMSTD0: Rotating Hinge Metal-Cased Reamer: Standard
• B278IMTRRHMSM0: Rotating Hinge Metal-Cased Reamer: Small
• B278IMTRRHMEXSM0: Rotating Hinge Metal-Cased Reamer: Extra-Small
• B278IMTRFH0: Fixed hinge Reamer
• B278IMTPRMFHSTD0: STD Positioning Plate: Holes
• B278IMTPRMFHSM0: SM Positioning Plate: Holes
• B278IMTPRMFHEXSM0: EXSM Positioning Plate: Holes
• B278IMTPRHPSTD0: STD Positioning Plate: Slots
• B278IMTPRHPSM0: SM Positioning Plate: Slots
• B278IMTPRHPEXSM0: EXSM Positioning Plate: Slots
• B278IMTIBJIGRST0: Tibial Cutting Guide: Rest
• B278IMTIBJIGROD0: Tibial Cutting Guide: Rod
• B278IMTIBJIGPRG0: Tibial Cutting Guide: Prongs
• B278IMPBIMPSTD0: Plastic Tibial Bearing Impactor: Standard
• B278IMOSTME150: Osteotome
• B278IMHAM0: Hammer
• B278IMGENIMP0: General Impactor
• B278IMCIRPR0: Circlip Pliers
• B278IMBCSTD0: Bush Compressor: Standard