510(k) · Cleared
ClearedMOTOTM Partial Knee & MOTO PFJ Systems 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 Nov 16, 2021 as substantially equivalent to K162084 (Medacta International S.A., 2017) and 2 other predicates after a 54-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Nov 16, 2021
- Review
- 54 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K880155 (1988). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
- 4 generations backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
- 3 generations backK073175 Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007
- 2 generations backK162084 MOTO Partial Knee SystemMedacta International S.A. · 2017
- 1 generation backK183029 MOTO Partial Knee SystemMedacta International S.A. · 2019
- This deviceK213071 MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A. · 2021
- Descendant · cites it directly · 0 of its ownK251618 MOTO Partial Knee System ExtensionMedacta International S.A. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K880155 | Miller/Galante Precoat Unicompartmental Knee | Zimmer, Inc. | 1988 | 1 |
| −4 | K033363 | Zimmer Unicompartmental Knee System | Zimmer, Inc. | 2004 | 3 |
| −3 | K073175 | Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | 2007 | — |
| −2 | K162084 | MOTO Partial Knee System | Medacta International S.A. | 2017 | — |
| −1 | K183029 | MOTO Partial Knee System | Medacta International S.A. | 2019 | — |
| 0 (this device) | K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021 | — |
| +1 | K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K162084 | MOTO Partial Knee SystemSummary page 5…the already cleared one (K200122) may be used in the following combinations: with the MOTO PFJ with the MOTO PFJ and with the MOTO Partial Knee System (K162084, K183029), GMK UNI (K162084), alone (without MOTO PFJ) with the GMK Primary or GMK Sphere devices (K090988,… | 2017 |
| * | K183029 | MOTO Partial Knee SystemSummary page 4…y predicate device 62084, Medacta International SA Additional predicate devices K183029, Medacta International SA TM MOTO PFJ System, K200122, Medacta International SA Additional refer… | 2019 |
| * | K200122 | MOTO PFJ SystemSummary page 4…onal SA Additional predicate devices K183029, Medacta International SA TM MOTO PFJ System, K200122, Medacta International SA Additional reference devices GMK Sphere E-cross, K202022, Medacta International SA… | 2020 |
| † | K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS… | 2020 |
| † | K202684 | GMK Total Knee System - TiNbN Coating | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251618 | MOTO Partial Knee System Extension | 2025 | 0 |
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 33 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 9 of the 18 ancestors have a recall of any class.
- Of its descendants, K251618 (Medacta International S.A., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K162084.
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. 2021, 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?
The MOTO™ 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…
Read the full statement (185 words)
The MOTO™ 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.
The MOTO™ PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases:
* Osteoarthritis, post-traumatic arthritis, polyarthritis, severe chondrocalcinosis of the patellofemoral joint.
* Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation).
* History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.
* Degeneration induced by dysplasia.
If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213071: MOTOTM Partial Knee & MOTO PFJ Systems Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213071
Report an extraction error
Are you the manufacturer?
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