AccessGUDID - DEVICE: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (B278SMBPR020)

GUDID

Device Identifier (DI) Information

Brand Name: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Version or Model: Smbpr02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SMBPR02
Company Name: ONKOS SURGICAL, INC.

Primary DI Number: B278SMBPR020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080254074 *Terms of Use
Previous DI: 05060296231996

Device Description: Bumper Pad STD

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33580	Uncoated knee tibia prosthesis, polyethylene	An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made entirely of polyethylene (PE) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092138	000
K133152	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Standard

Device Record Status

Public Device Record Key: 74e1273c-c121-4a5a-b49f-7316af5381a2
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024