510(k) · Cleared
ClearedAchieve Partial Knee System - Porous Coated CoCrMo Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ignite Orthomotion · NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Cleared on Sep 2, 2025 as substantially equivalent to K242307 (Ignite Orthomotion, 2024) after a 68-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Sep 2, 2025
- Review
- 68 days
- Class
- Class II
- Product code
- NJD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K943462 (1994). 40 ancestors in all, the oldest K880155 (1988). No later device cites it as a predicate yet.
- Root · 9 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 2 generations backK133811 Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014
- 1 generation backK242307 ACHIEVE Partial Knee SystemIgnite Orthomotion · 2024
- This deviceK251975 Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion · 2025
Show all 9 generations
- Root · 9 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 8 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 7 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 6 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 5 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 4 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 3 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 2 generations backK133811 Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014
- 1 generation backK242307 ACHIEVE Partial Knee SystemIgnite Orthomotion · 2024
- This deviceK251975 Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −8 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −7 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −6 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −5 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −4 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −3 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −2 | K133811 | Restoris Porous Partial Knee System | Mako Surgical Corp. | 2014 | — |
| −1 | K242307 | ACHIEVE Partial Knee System | Ignite Orthomotion | 2024 | — |
| 0 (this device) | K251975 | Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component | Ignite Orthomotion | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NJD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NJD device
- #1 K242307 ACHIEVE Partial Knee Systemscore 13.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242307 | ACHIEVE Partial Knee SystemSummary page 5…t femorotibial metal/polymer non-constrained cemented prosthesis; (21 CFR §888.3520); Class II Product Codes: NJD, HSX Predicate Devices: K242307(Primary) - ACHIEVE Partial Knee System, Ignite OrthoMotion Reference Devices: K243768 – iTotal Identity Cruciate Retaining 3D… | 2024 |
| † | K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | 2025 |
| † | K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | 2021 |
| † | K190085 | Journey II Unicompartmental Knee System | 2019 |
| † | K202716 | Ignite Anatomic Shoulder System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 20 of the 40 ancestors have a recall of any class.
How does its category compare?
All NJD devicesNJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NJD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NJD
Too few NJD 510(k)s in any year since 2007 to give a median.
Recalls per year · NJD
No recall names NJD since 2007.
Adverse event reports per year · NJD
4in 2025
MAUDE reports naming product code NJD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 34 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty of the medial and/or lateral femorotibial compartments to treat one or more of the following conditions: • Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis. • Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty. • As an alternative to tibial osteotomy in patients…
Read the full statement (100 words)
The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty of the medial and/or lateral femorotibial compartments to treat one or more of the following conditions:
• Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis.
• Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty.
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
Fixation Methods
Tibial trays and femoral components with engineered porous surfaces are intended for cemented or cementless use.
Tibial trays and femoral components without engineered porous surfaces are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251975: Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251975
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026