AccessGUDID - DEVICE: SurgiCase Planner (E314SURGICASEKNEEPLAN0)

GUDID

Device Identifier (DI) Information

Brand Name: SurgiCase Planner
Version or Model: SurgiCase Knee Planner
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SurgiCase Knee Planner
Company Name: Materialise NV

Primary DI Number: E314SURGICASEKNEEPLAN0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 373139427 *Terms of Use

Device Description: SurgiCase Knee Planner

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:	No
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?
50484	CAD/CAM software	A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150928	000
K162273	000
K172650	000
K173445	000
K173970	000
K202207	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 316ef4d7-a42e-4e9c-8938-015bbb96f3ca
Public Version Date: March 10, 2025
Public Version Number: 3
DI Record Publish Date: October 17, 2018