AccessGUDID - DEVICE: Optimotion Blue CR HCCR Total Knee System (B6961014L3415)

GUDID

Device Identifier (DI) Information

Brand Name: Optimotion Blue CR HCCR Total Knee System
Version or Model: 1014-L-3415
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OPTIMOTION IMPLANTS LLC

Primary DI Number: B6961014L3415
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056559377 *Terms of Use

Device Description: TIBIAL INSERT HP PS SZ 4, 15 MM

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?
33664	Cruciate-retaining total knee prosthesis	A sterile implantable artificial substitute for a knee joint typically designed to replace all the articulating surfaces of the damaged/degenerative (e.g., arthritic) joint [total knee arthroplasty (TKA)]; it is designed to be implanted with retention of the posterior cruciate ligament. It typically includes femoral, tibial, and patellar components that articulate and with parts made of metal, ceramic, and/or polyethylene (PE). The device may be implanted with or without bone cement and is typically used in cases where bone stock is good and supporting ligaments provide adequate stability.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191084	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
No Device Sizes

Device Record Status

Public Device Record Key: 7bd293df-a723-479c-817b-7f0ae848f5cc
Public Version Date: September 19, 2024
Public Version Number: 1
DI Record Publish Date: September 11, 2024