510(k) · Cleared
Recalled · Class II · 2021Univation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap Implant Systems, LLC · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Oct 17, 2013 as substantially equivalent to K081293 (Aesculap Implant Systems, Inc., 2008) after a 176-day review. Its family tree reaches back 6 generations to 1992. It has been recalled 8 times.
- Decided
- Oct 17, 2013
- Review
- 176 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915192 (1992). 26 ancestors in all, the oldest K853661 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 5 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 4 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- 3 generations backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- 2 generations backK071220 Columbus Total Knee System asAesculap Implant Systems, Inc. · 2007 · Recalled
- 1 generation backK081293 Univation Unicondylar Knee SystemAesculap Implant Systems, Inc. · 2008 · Recalled
- This deviceK131167 UnivationAesculap Implant Systems, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −5 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −4 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| −3 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| −2 | K071220 | Columbus Total Knee System as | Aesculap Implant Systems, Inc. | 2007 | 1 |
| −1 | K081293 | Univation Unicondylar Knee System | Aesculap Implant Systems, Inc. | 2008 | 8 |
| 0 (this device) | K131167 | Univation | Aesculap Implant Systems, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K081293 | Univation Unicondylar Knee SystemSummary page 1…lap Implant Systems®, LLC. UNIVATION® Unicompartmental Knee System is substantially equivalent to the original UNIVATION® Unicompartmental Knee System cleared in 510O(K) K081293. The indications for use are equivalent to the predicate. DEVICE DESCRIPTION The UNIVATION® Unicompartmental Knee System is a pro… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2021 | Class II | Z-2510-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Mar 19, 2021 | Class II | Z-2512-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Mar 19, 2021 | Class II | Z-2514-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Mar 19, 2021 | Class II | Z-2516-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Mar 19, 2021 | Class II | Z-2509-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Mar 19, 2021 | Class II | Z-2511-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Mar 19, 2021 | Class II | Z-2515-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
| Mar 19, 2021 | Class II | Z-2513-2021 | Unknown/Undetermined by firm | Malfunction- loosening of the implant resulting in a potential revision surgery |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 14 of the 26 ancestors have a recall of any class.
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. 2013, this device’s year, is highlighted.
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 UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131167: Univation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131167
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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