510(k) · Cleared
ClearedGenesis Unicondylar Uhmwpe Articular Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Feb 19, 2010 as substantially equivalent to K912735 (Smith & Nephew Richards, Inc., 1991) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Feb 19, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912735 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK912735 Genesis Unicompartmental Knee SystemSmith & Nephew Richards, Inc. · 1991 · Recalled
- 1 generation backK061011 Competitor Unicondylar Knee Tibial BaseplateSmith & Nephew, Inc. · 2006
- This deviceK100197 Genesis Unicondylar Uhmwpe Articular InsertsSmith & Nephew, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912735 | Genesis Unicompartmental Knee System | Smith & Nephew Richards, Inc. | 1991 | 2 |
| −1 | K061011 | Competitor Unicondylar Knee Tibial Baseplate | Smith & Nephew, Inc. | 2006 | — |
| 0 (this device) | K100197 | Genesis Unicondylar Uhmwpe Articular Inserts | Smith & Nephew, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K912735 | Genesis Unicompartmental Knee SystemSummary page 1…cular inserts have been designed and developed by Smith & Nephew Orthopaedics. The subject devices were designed to be used with existing Genesis Unicondylar baseplates (K91 2735) and are intended to replace either the medial or lateral tibial. compartment of the knee. The overall design of the articular in… | 1991 |
| * | K061011 | Competitor Unicondylar Knee Tibial BaseplateSummary page 1…rall indications, and materials: * Smith & Nephew Genesis Unicompartmental Articular Knee Inserts (K91 2735) * Smith &Nephew Journey Unicondylar Articular KneelInserts (K061 011) SDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 14.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 8 other devices also cite its predicate K912735.
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. 2010, this device’s year, is highlighted.
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 Genesis Unicondylar UHMWPe Articular Inserts are indicated for restoring either compartment of a knee that has been affected by the following:
* Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
* Correction of functional deformity;
* Revision procedures where other treatments or devices have failed; and
* Treatment of fractures that are unmanageable using other techniques.
The implants are single use only and are designed to be used in combination with Genesis Unicondylar baseplates that are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100197: Genesis Unicondylar Uhmwpe Articular Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100197
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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