FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Truliant Porous Femoral Components
K Number: K181794
·
Decision Sep 28, 2018
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
142
Applicant Total
186
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Truliant Porous Femoral Components
- K Number
- K181794
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3565
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exactech, Inc.
- Date Received
- July 5, 2018
- Decision Date
- September 28, 2018
- Product Code
- MBH
- 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 |
|---|---|---|---|
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBH), ordered by most recent decision date.
Zimmer® Persona® Personalized Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
FDA 510(k)
FDA Class 2
·Orthopedic
GMK 3D Metal Tibial Tray Extension
FDA 510(k)
FDA Class 2
·Orthopedic
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
FDA 510(k)
FDA Class 2
·Orthopedic
Active-V Total Knee System; World Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Balanced Knee System TriMax Porous Femoral Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Exactech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260583 | Equinoxe® Shoulder System | Apr 14, 2026 | Substantially Equivalent |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Dec 1, 2025 | Substantially Equivalent |
| K243448 | Equinoxe® Shoulder System | Aug 1, 2025 | Substantially Equivalent |
| K243275 | Equinoxe® Scapula Fracture System | Jun 26, 2025 | Substantially Equivalent |
| K243839 | Alteon® HA Femoral Stems | Mar 10, 2025 | Substantially Equivalent |
| K240393 | Exactech® TRULIANT® Knee System | Oct 3, 2024 | Substantially Equivalent |
| K233482 | Equinoxe® Central Screw Baseplate System | Jul 18, 2024 | Substantially Equivalent |
| K230717 | Exactech® Vantage® Total Ankle System | Oct 12, 2023 | Substantially Equivalent |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | Sep 25, 2023 | Substantially Equivalent |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Sep 14, 2023 | Substantially Equivalent |