510(k) · Cleared
Recalled · Class II · 2017Miller/Galante Precoat Unicompartmental Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jul 11, 1995 after a 428-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled once.
- Decided
- Jul 11, 1995
- Review
- 428 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK942263 Miller/Galante Precoat Unicompartmental Knee SystemZimmer, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK161592 Persona Partial Knee SystemBiomet, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK212870 TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK081293 Univation Unicondylar Knee SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK261609 Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK251771 Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161592Persona Partial Knee SystemBiomet, Inc. · 2016 · cites it directly5descendants
- K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd. · 2022 · 2 generations on2descendants
- K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc. · 2008 · cites it directly1descendant
- K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026 · 3 generations on0descendants
- K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942263 | Miller/Galante Precoat Unicompartmental Knee System | Zimmer, Inc. | 1995 | — |
| +1 | K161592 | Persona Partial Knee System | Biomet, Inc. | 2016 | 2 |
| +2 | K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| +1 | K081293 | Univation Unicondylar Knee System | Aesculap Implant Systems, Inc. | 2008 | 8 |
| +3 | K261609 | Freedom Partial Knee System | Maxx Orthopedics, Inc. | 2026 | — |
| +3 | K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-1055-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161592 (Biomet, Inc., 2016) has gone furthest, with 5 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K942263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K942263: Miller/Galante Precoat Unicompartmental Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K942263
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026