Model: SurgiCase Knee Planner
Catalog: SurgiCase Knee Planner
DI: 05404028001257
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
SurgiCase Knee Planner
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2054524b-f15e-4cd3-bec1-3385e4fc5eb7
Distribution Status:
In Commercial Distribution
DUNS Number:
373139427
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05404028001257
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 50484
Name: CAD/CAM software
Definition:
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.
FDA Product Codes
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
Premarket Submissions
Item #1 - Submission Number:
K150928
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K162273
Item #2 - Supplement Number:
000
Item #3 - Submission Number:
K172650
Item #3 - Supplement Number:
000
Item #4 - Submission Number:
K173445
Item #4 - Supplement Number:
000
Item #5 - Submission Number:
K173970
Item #5 - Supplement Number:
000
Item #6 - Submission Number:
K202207
Item #6 - Supplement Number:
000
Item #7 - Submission Number:
K221337
Item #7 - Supplement Number:
000
Item #8 - Submission Number:
K251554
Item #8 - Supplement Number:
000
Item #9 - Submission Number:
K253793
Item #9 - Supplement Number:
000