510(k) · Cleared
ClearedSulzer Orthopedics Allegretto Unicompartmental Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Sep 19, 2001 after an 89-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Sep 19, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK011954 Sulzer Orthopedics Allegretto Unicompartmental KneeSulzer Orthopedics, Inc. · 2001
- 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 · 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
- Descendant · 2 generations on · 0 of its ownK251834 Persona Partial KneeZimmer Biomet · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161592Persona Partial Knee SystemBiomet, Inc. · 2016 · cites it directly5descendants
- K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd. · 2022 · 2 generations on2descendants
- K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc. · 2026 · 3 generations on0descendants
- K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd. · 2025 · 3 generations on0descendants
- K251834Persona Partial KneeZimmer Biomet · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011954 | Sulzer Orthopedics Allegretto Unicompartmental Knee | Sulzer Orthopedics, Inc. | 2001 | — |
| +1 | K161592 | Persona Partial Knee System | Biomet, Inc. | 2016 | 2 |
| +2 | K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022 | — |
| +3 | K261609 | Freedom Partial Knee System | Maxx Orthopedics, Inc. | 2026 | — |
| +3 | K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025 | — |
| +2 | K251834 | Persona Partial Knee | Zimmer Biomet | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (9)
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 |
|---|---|---|---|
| * | — | Stryker Howmedica Osteonics SCR Unicompartmental Knee Named without a submission number | |
| * | — | Sulzer Orthopedics Natural Knee Uni Knee Named without a submission number | |
| * | — | Styker Howmedica Osteonics PCA Named without a submission number | |
| * | — | Styker Howmedica Osteonics Minimally Invasive Uni Knees Named without a submission number | |
| * | — | Biomet Repicci II Named without a submission number | |
| * | — | Biomet Genus Uni Knees Named without a submission number | |
| * | — | Smith & Nephew Genesis Uni Knee Named without a submission number | |
| * | — | J & J Depuy PFC Uni Knee Named without a submission number | |
| * | — | Zimmer Miller/Galante Uni Knee Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161592 | Persona Partial Knee System | 2016 | 5 |
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?
- 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 | — |
What is it indicated for?
The Allegretto Unicompartmental Knee consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to replace the medial or lateral component of the femorotibial knee joint, damaged as a result of non-inflammatory joint disease, or trauma. The device is a single-use implant intended for cemented use only. The Allegretto Unicompartmental Knee system is indicated for use in treatment of: 1. Unicompartmental…
Read the full statement (108 words)
The Allegretto Unicompartmental Knee consists of a distal femoral resurfacing component and a proximal tibial resurfacing component. It is intended to replace the medial or lateral component of the femorotibial knee joint, damaged as a result of non-inflammatory joint disease, or trauma. The device is a single-use implant intended for cemented use only.
The Allegretto Unicompartmental Knee system is indicated for use in treatment of:
1. Unicompartmental noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and arthritis secondary to a variety of diseases and anomalies.
2. Passively correctable valgus-varus deformity and moderate flexion contracture.
3. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
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/K011954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011954: Sulzer Orthopedics Allegretto Unicompartmental Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011954
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026