510(k) K242307
- Device
- ACHIEVE Partial Knee System
- Applicant
- Ignite Orthomotion
- 510(k) number
- K242307
- Product code
- NJD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-16
- Date received
- 2024-08-05
- Regulation
- 888.3535
- Classification name
- Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Russell Parrott
- Address
- 700 Park Ave. Suite F Winona Lake IN US 46590 46590
FDA Registration Numbers#
- 3008744062
- 1219602
- 1526534
- 3013176080
- 3015542154
- 1424263
- 2249697
- 3011683674
- 3003387384
- 3016090213
- 1822565
- 3015207155
- 3010375065
- 1222928
- 1020279
- 3017410889
- 3007366790
- 1643264
- 3035366890
Source Documents#
Other 510(k) Records For Product Code NJD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion | 2025-09-02 |
| K222653 | JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System | Smith+Nephew, Inc. | 2022-10-28 |
| K190439 | Engage™ Partial Knee System | Engage Uni, LLC | 2019-11-21 |
| K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | Mako Surgical Corp. | 2014-07-08 |