510(k) · Cleared
ClearedActive Unicompartmental Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Australian Surgical Design & Manufacture · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on May 17, 2006 as substantially equivalent to K971938 (Biomet, Inc., 1997) after a 90-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- May 17, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971938 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- This deviceK060412 Active Unicompartmental Knee SystemAustralian Surgical Design & Manufacture · 2006
- Descendant · cites it directly · 0 of its ownK072704 Unicompartmental KneeValpo Orthopedic Technology, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072704Unicompartmental KneeValpo Orthopedic Technology, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| 0 (this device) | K060412 | Active Unicompartmental Knee System | Australian Surgical Design & Manufacture | 2006 | — |
| +1 | K072704 | Unicompartmental Knee | Valpo Orthopedic Technology, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 HRY? 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 HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K971938 | Repicci II Unicondylar KneeSummary page 1…Knee prosthesis, Unicompartmental. Substantial Equivalence: The Active Unicompartmental Knee issubstantially equivalent to the Repicci 11 Unicondylar Knee, K971938. Product Description: Device The Active Unicompartmental Knee System is a modular re-surfacing uni- compartmental knee implan… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072704 | Unicompartmental Knee | 2008 | 0 |
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?
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, 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 | 3 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Active Unicompartmental Knee System is a modular unicompartmental system that is intended to resurface one diseased or damaged condyle of a knee where the other condyle remains intact. It is intended to be used only with bone cement in patients suffering from the following conditions:
Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
Inflammatory degenerative joint disease excluding rheumatoid arthritis
Correction of functional deformity such as varus or valgus deformities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060412: Active Unicompartmental Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060412
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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