510(k) · Cleared
ClearedMOTO Partial Knee System Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jul 24, 2025 as substantially equivalent to K213071 (Medacta International S.A., 2021) and 3 other predicates after a 58-day review. Its family tree reaches back 6 generations to 1988.
- Decided
- Jul 24, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K880155 (1988). 27 ancestors in all, the oldest K873601 (1988). No later device cites it as a predicate yet.
- Root · 6 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
- 5 generations backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
- 4 generations backK073175 Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007
- 3 generations backK162084 MOTO Partial Knee SystemMedacta International S.A. · 2017
- 2 generations backK183029 MOTO Partial Knee SystemMedacta International S.A. · 2019
- 1 generation backK213071 MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A. · 2021
- This deviceK251618 MOTO Partial Knee System ExtensionMedacta International S.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K880155 | Miller/Galante Precoat Unicompartmental Knee | Zimmer, Inc. | 1988 | 1 |
| −5 | K033363 | Zimmer Unicompartmental Knee System | Zimmer, Inc. | 2004 | 3 |
| −4 | K073175 | Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | 2007 | — |
| −3 | K162084 | MOTO Partial Knee System | Medacta International S.A. | 2017 | — |
| −2 | K183029 | MOTO Partial Knee System | Medacta International S.A. | 2019 | — |
| −1 | K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021 | — |
| 0 (this device) | K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K213071 | MOTOTM Partial Knee & MOTO PFJ Systems ExtensionSummary page 5…cate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • MOTO Partial Knee & MOTO PFJ Systems Extension, K213071, Medacta International SA Additional Predicate devices: • Oxford® Fixed Lateral Bearing Partial Knee Replacemen… | 2021 |
| * | K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Summary page 5…& MOTO PFJ Systems Extension, K213071, Medacta International SA Additional Predicate devices: • Oxford® Fixed Lateral Bearing Partial Knee Replacement, K133940, Biomet UK, Ltd • MOTO Partial Knee System, K162084, Medacta International SA • MOTO Lateral Partial Knee Sys… | 2014 |
| * | K162084 | MOTO Partial Knee SystemSummary page 5…A Additional Predicate devices: • Oxford® Fixed Lateral Bearing Partial Knee Replacement, K133940, Biomet UK, Ltd • MOTO Partial Knee System, K162084, Medacta International SA • MOTO Lateral Partial Knee System, K183029, Medacta International SA Reference device:… | 2017 |
| * | K183029 | MOTO Partial Knee SystemSummary page 5…g Partial Knee Replacement, K133940, Biomet UK, Ltd • MOTO Partial Knee System, K162084, Medacta International SA • MOTO Lateral Partial Knee System, K183029, Medacta International SA Reference device: • GMK Total Knee System - TiNbN Coating, K202684, Medacta International SA I… | 2019 |
| † | K202684 | GMK Total Knee System - TiNbN Coating | 2020 |
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 37 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 15 of the 27 ancestors have a recall of any class.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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 · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MOTO Medial, MOTO Lateral and MOTO Sphere Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251618: MOTO Partial Knee System Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251618
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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