510(k) · Cleared
ClearedGMK Uni
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 Apr 14, 2017 as substantially equivalent to K073175 (Smith & Nephew, Inc., 2007) and 2 other predicates after a 294-day review. Its family tree reaches back 3 generations to 1988. 2 later devices descend from it.
- Decided
- Apr 14, 2017
- Review
- 294 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K880155 (1988). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
- 2 generations backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
- 1 generation backK073175 Journey Unicondylar Femoral ImplantSmith & Nephew, Inc. · 2007
- This deviceK161741 GMK UniMedacta International S.A. · 2017
- Descendant · cites it directly · 1 of its ownK203341 ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
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 |
|---|---|---|---|---|---|
| −3 | K880155 | Miller/Galante Precoat Unicompartmental Knee | Zimmer, Inc. | 1988 | 1 |
| −2 | K033363 | Zimmer Unicompartmental Knee System | Zimmer, Inc. | 2004 | 3 |
| −1 | K073175 | Journey Unicondylar Femoral Implant | Smith & Nephew, Inc. | 2007 | — |
| 0 (this device) | K161741 | GMK Uni | Medacta International S.A. | 2017 | — |
| +1 | K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021 | — |
| +2 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K073175 | Journey Unicondylar Femoral ImplantSummary page 4…21 CFR 888.3520 Device Class: II PREDICATE DEVICE INFORMATION Primary predicates: 510(k) Product 510(k) Holder K073175 Journey Smith & Nephew Additional predicates: 510(k) Product… | 2007 |
| * | K102069 | Journey Unicondylar Tibial BaseplatesSummary page 4…510(k) Holder K073175 Journey Smith & Nephew Additional predicates: 510(k) Product 510(k) Holder K102069 Journey Smith & Nephew K033363 UNI Zimmer GMK® UNI Tradi… | 2010 |
| * | K033363 | Zimmer Unicompartmental Knee SystemSummary page 4…Smith & Nephew Additional predicates: 510(k) Product 510(k) Holder K102069 Journey Smith & Nephew K033363 UNI Zimmer GMK® UNI Traditional 510(k)… | 2004 |
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 |
|---|---|---|---|
| K203341 | ACS LD Uni FB Knee System | 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 29 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K203341 (Implantcast GmbH, 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 devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 GMK(R) UNI knee prosthesis 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 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/K161741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161741: GMK Uni.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161741
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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