510(k) · Cleared
ClearedMOTO PFJ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Apr 20, 2020 as substantially equivalent to K070695 (Zimmer, Inc., 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 20, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- KRR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933785 (1995). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 3 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 2 generations backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- 1 generation backK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · Recalled
- This deviceK200122 MOTO PFJ SystemMedacta International S.A. · 2020
- Descendant · cites it directly · 1 of its ownK213071 MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK251618 MOTO Partial Knee System ExtensionMedacta International S.A. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −3 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −2 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| −1 | K070695 | Zimmer Patellofemoral Joint Prosthesis | Zimmer, Inc. | 2007 | 5 |
| 0 (this device) | K200122 | MOTO PFJ System | Medacta International S.A. | 2020 | — |
| +1 | K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | Medacta International S.A. | 2021 | — |
| +2 | K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 KRR? 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 KRR device
- #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K070695 | Zimmer Patellofemoral Joint ProsthesisSummary page 4…60 Device Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: ¾ Patellofemoral joint prosthesis, K070695, Zimmer ¾ NexGen Prolong All-poly patella, K072281, Zimmer In addition, the following Reference device is cited within th… | 2007 |
| * | K072281 | Nexgen Prolong All-Poly PatellaSummary page 4…Device Substantial equivalence is claimed to the following devices: ¾ Patellofemoral joint prosthesis, K070695, Zimmer ¾ NexGen Prolong All-poly patella, K072281, Zimmer In addition, the following Reference device is cited within the submission: ¾ GMK (K090988), Medacta Internation… | 2007 |
| † | K090988 | GMK Total Knee System | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213071 | MOTOTM Partial Knee & MOTO PFJ Systems Extension | 2021 | 1 |
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 25 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K213071 (Medacta International S.A., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K070695.
How does its category compare?
All KRR devicesKRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KRR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KRR
116in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRR
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRR
36in 2025
MAUDE reports naming product code KRR, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 116 | 0 | 0 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 9 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 1 | — | 1 | 14 |
| 2017 | 0 | — | 2 | 15 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 3 | 9 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).…
Read the full statement (111 words)
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/K200122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200122: MOTO PFJ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200122
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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