FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACHIEVE Partial Knee System
K Number: K242307
·
Decision Dec 16, 2024
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
4
Applicant Total
2
Review Days
133
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Basic Information
- Device Name
- ACHIEVE Partial Knee System
- K Number
- K242307
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3535
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ignite Orthomotion
- Date Received
- August 5, 2024
- Decision Date
- December 16, 2024
- Product Code
- NJD
- 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 |
|---|---|---|---|
| NJD | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NJD), ordered by most recent decision date.
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
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JOURNEY II UK and ENGAGE Cementless Partial Knee System
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Engage Partial Knee System
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FDA Class 2
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RESTORIS POROUS PARTIAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
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Other Clearances by Ignite Orthomotion
| K Number | Device Name | ||
|---|---|---|---|
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Sep 2, 2025 | Substantially Equivalent |