510(k) Report

510(k) · Cleared

Cleared

MOTO Partial Knee System

K183029510(k) TraditionalCleared Jan 30, 201990-day reviewClass II21 CFR 888.3520

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medacta International S.A. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Cleared on Jan 30, 2019 as substantially equivalent to K073175 (Smith & Nephew, Inc., 2007) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it.

Decided
Jan 30, 2019
Review
90 days
Class
Class II
Product code
HSX
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K880155 (1988). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor1991: 1 other ancestor2021: 1 descendant cleared2025: 1 descendant clearedK880155 · Miller/Galante Precoat Unicompartmental Knee · Zimmer, Inc. · 1988 · recalledK033363 · Zimmer Unicompartmental Knee System · Zimmer, Inc. · 2004 · recalledK073175 · Journey Unicondylar Femoral Implant · Smith & Nephew, Inc. · 2007K162084 · MOTO Partial Knee System · Medacta International S.A. · 20171990200020102020
  1. Root · 4 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
  2. 3 generations backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
  3. 2 generations backK073175 Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007
  4. 1 generation backK162084 MOTO Partial Knee SystemMedacta International S.A. · 2017
  5. This deviceK183029 MOTO Partial Knee SystemMedacta International S.A. · 2019
  6. Descendant · cites it directly · 1 of its ownK213071 MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A. · 2021
  7. Descendant · cites it directly · 0 of its ownK251618 MOTO Partial Knee System ExtensionMedacta International S.A. · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A. · 2021 · cites it directly1descendant
  • K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K880155Miller/Galante Precoat Unicompartmental KneeZimmer, Inc.19881
−3K033363Zimmer Unicompartmental Knee SystemZimmer, Inc.20043
−2K073175Journey Unicondylar Femoral ImplantSmith & Nephew, Inc.2007—
−1K162084MOTO Partial Knee SystemMedacta International S.A.2017—
0 (this device)K183029MOTO Partial Knee SystemMedacta International S.A.2019—
+1K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.2021—
+1K251618MOTO Partial Knee System ExtensionMedacta International S.A.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200110
200310
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202510
FIG. 1 — Lineage of K183029, 1988–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K073175Journey Unicondylar Femoral Implant
Summary page 4
…Device Classification II III. Predicate Device Substantial equivalence is claimed to the following devices: • JOURNEY Unicondylar Femoral Implant - K073175, Smith & Nephew INC.; • JOURNEY Unicondylar Tibial Baseplates - K102069, Smith & Nephew INC.; • ZIMMER Unicompartimenta…
Smith & Nephew, Inc.2007—
*K102069Journey Unicondylar Tibial Baseplates
Summary page 4
…uivalence is claimed to the following devices: • JOURNEY Unicondylar Femoral Implant - K073175, Smith & Nephew INC.; • JOURNEY Unicondylar Tibial Baseplates - K102069, Smith & Nephew INC.; • ZIMMER Unicompartimental Knee System - K033363, Zimmer, INC.; and • MOTO™ Partial Knee System -…
Smith & Nephew, Inc.2010—
*K033363Zimmer Unicompartmental Knee System
Summary page 4
…emoral Implant - K073175, Smith & Nephew INC.; • JOURNEY Unicondylar Tibial Baseplates - K102069, Smith & Nephew INC.; • ZIMMER Unicompartimental Knee System - K033363, Zimmer, INC.; and • MOTO™ Partial Knee System - K162084, Medacta International SA. IV. Device Description The MOTO™ La…
Zimmer, Inc.20043
*K162084MOTO Partial Knee System
Summary page 4
…Unicondylar Tibial Baseplates - K102069, Smith & Nephew INC.; • ZIMMER Unicompartimental Knee System - K033363, Zimmer, INC.; and • MOTO™ Partial Knee System - K162084, Medacta International SA. IV. Device Description The MOTO™ Lateral Partial Knee System is designed for cemented use in part…
Medacta International S.A.2017—

Also cleared against K073175: 6 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211
K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250

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 3 companies; a new generation was cleared every 9.0 years on median.
  • 3 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.
  • 6 other devices also cite its predicate K073175.

How does its category compare?

All HSX devices

HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · HSX

4in 2025

2007: 62008: 42009: 22010: 32011: 12012: 52013: 22015: 12016: 32017: 52018: 22019: 72020: 42021: 72022: 22023: 12024: 42025: 42026 (partial year): 2
2007high 7 (2019) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSX

59in 2025

2007: 33 days median2008: 102 days median2010: 74 days median2012: 88 days median2016: 147 days median2017: 160 days median2019: 90 days median2020: 40 days median2021: 81 days median2024: 133 days median2025: 59 days median
2007high 160 (2017) · low 33 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSX

2in 2020

2009: 492013: 12016: 12017: 42020: 2
2007high 49 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSX

175in 2025

2007: 62008: 42009: 212010: 582011: 1142012: 832013: 792014: 662015: 572016: 1072017: 1132018: 1592019: 1772020: 2732021: 2402022: 2572023: 2312024: 1722025: 175
2007high 273 (2020) · low 4 (2008)2025

MAUDE reports naming product code HSX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200763306
2008410204
20092—4921
2010374058
20111—0114
2012588083
20132—179
20140—066
20151—057
201631471107
201751604113
20182—0159
20197900177
20204402273
20217810240
20222—0257
20231—0231
202441330172
20254590175
20262—0—

What is it indicated for?

The MOTO™ Lateral 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 side of the joint is affected due to the compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K183029: MOTO Partial Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183029

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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