510(k) · Cleared
ClearedWhiteside Ortholoc II Unicondylar Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dow Corning Wright · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Aug 31, 1988 after a 127-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 31, 1988
- Review
- 127 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK881779 Whiteside Ortholoc II Unicondylar Knee SystemDow Corning Wright · 1988
- Descendant · cites it directly · 3 of its ownK014171 Advance Unicondylar Knee SystemWrightmedicaltechnologyinc · 2002
- Descendant · 2 generations on · 1 of its ownK022211 HLS Uni Evolution ProsthesisTornier · 2003
- Descendant · 3 generations on · 0 of its ownK120262 HLS Uni Evolution & U-KneetecTornier, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK100973 Evolution Unicondylar Knee SystemWrightmedicaltechnologyinc · 2010
Most influential descendants
Showing 4 of 4 · See all- K014171Advance Unicondylar Knee SystemWrightmedicaltechnologyinc · 2002 · cites it directly3descendants
- K022211HLS Uni Evolution ProsthesisTornier · 2003 · 2 generations on1descendant
- K120262HLS Uni Evolution & U-KneetecTornier, Inc. · 2012 · 3 generations on0descendants
- K100973Evolution Unicondylar Knee SystemWrightmedicaltechnologyinc · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881779 | Whiteside Ortholoc II Unicondylar Knee System | Dow Corning Wright | 1988 | — |
| +1 | K014171 | Advance Unicondylar Knee System | Wrightmedicaltechnologyinc | 2002 | — |
| +2 | K022211 | HLS Uni Evolution Prosthesis | Tornier | 2003 | — |
| +3 | K120262 | HLS Uni Evolution & U-Kneetec | Tornier, Inc. | 2012 | — |
| +1 | K100973 | Evolution Unicondylar Knee System | Wrightmedicaltechnologyinc | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (4)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K014171 (Wrightmedicaltechnologyinc, 2002) has gone furthest, with 3 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/K881779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881779: Whiteside Ortholoc II Unicondylar 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/K881779
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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