FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
K Number: K230416
·
Decision May 19, 2023
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
85
Applicant Total
92
Review Days
92
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Basic Information
- Device Name
- Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
- K Number
- K230416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3510
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker
- Date Received
- February 16, 2023
- Decision Date
- May 19, 2023
- Product Code
- KRO
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KRO), ordered by most recent decision date.
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
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ATTUNE Revision Hinge Knee
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EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
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ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
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