FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DePuy ATTUNE Knee System
K Number: K252887
·
Decision May 22, 2026
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
11
Applicant Total
207
Review Days
254
Basic Information
- Device Name
- DePuy ATTUNE Knee System
- K Number
- K252887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Orthopaedics, Inc.
- Date Received
- September 10, 2025
- Decision Date
- May 22, 2026
- Product Code
- OIY
- 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 |
|---|---|---|---|
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K193540 | TRUMATCH Personalized Solutions | Jun 16, 2020 | Substantially Equivalent |
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| K192946 | DePuy Corail AMT Hip Prosthesis | Nov 26, 2019 | Substantially Equivalent |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | Nov 26, 2019 | Substantially Equivalent |