FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
K Number: K243768
·
Decision Mar 27, 2025
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
142
Applicant Total
6
Review Days
111
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Basic Information
- Device Name
- iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
- K Number
- K243768
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3565
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Restor3D, Inc.
- Date Received
- December 6, 2024
- Decision Date
- March 27, 2025
- 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 |
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Other Clearances by Restor3D, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252067 | Velora Acetabular System | Dec 5, 2025 | Substantially Equivalent |
| K242356 | TIDAL Fusion Cage System | Mar 24, 2025 | Substantially Equivalent |
| K240591 | restor3d Kinos Axiom Total Ankle System | Apr 29, 2024 | Substantially Equivalent |
| K201393 | restor3d MTP Implant | May 25, 2022 | Substantially Equivalent |
| K201314 | Restor3d Utility Wedge | Jun 17, 2021 | Substantially Equivalent |