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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K261734
Device Name Klassic Infection Spacer System
Applicant
Total Joint Orthopedics, Inc.
1567 E. Stratford Ave.
Salt Lake City,  UT  84106
Applicant Contact Georgia Murray
Correspondent
Arthroplasty Regulatory Consulting
1433 E. Mulberry Way
Sandy,  UT  84093
Correspondent Contact Chris Weaber
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBB  
Date Received05/26/2026
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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