FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
iTotal® Identity Posterior Stabilized Knee Replacement System
K Number: K201023
·
Decision Jun 16, 2020
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
60
Review Days
57
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Basic Information
- Device Name
- iTotal® Identity Posterior Stabilized Knee Replacement System
- K Number
- K201023
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conformis, Inc.
- Date Received
- April 20, 2020
- Decision Date
- June 16, 2020
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Conformis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | Sep 8, 2023 | Substantially Equivalent |
| K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | Jul 21, 2023 | Substantially Equivalent |
| K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | Jul 17, 2023 | Substantially Equivalent |
| K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | May 26, 2023 | Substantially Equivalent |
| K231178 | ACTERA hip system | May 23, 2023 | Substantially Equivalent |
| K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | Apr 27, 2023 | Substantially Equivalent |
| K221104 | Actera hip system | Aug 4, 2022 | Substantially Equivalent |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Jul 26, 2022 | Substantially Equivalent |
| K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | May 10, 2022 | Substantially Equivalent |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | Nov 10, 2021 | Substantially Equivalent |