510(k) · Cleared
ClearedSIGMA High Performance (HP) Partial Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Apr 16, 2020 as substantially equivalent to K070849 (DePuy Orthopaedics, Inc., 2007) and 3 other predicates after a 118-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Apr 16, 2020
- Review
- 118 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K943462 (1994). 19 ancestors in all, the oldest K910968 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 4 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 3 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 2 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 1 generation backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- This deviceK193549 SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −4 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −3 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −2 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −1 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| 0 (this device) | K193549 | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K070849 | Depuy GCK Femoral and Tibial ComponentsSummary page 4…y: 21 CFR 888.3560 Product Code(s) Primary: HRY Secondary: OIY Legally marketed device(s) to which K070849 DEPUY GCK (SIGMA HP Partial) FEMORAL AND TIBIAL COMPONENTS equivalence is claimed K070267 DEPUY GCK (SIGMA HP P… | 2007 |
| * | K070267 | Depuy GCK Tibial ComponentsSummary page 4…Secondary: OIY Legally marketed device(s) to which K070849 DEPUY GCK (SIGMA HP Partial) FEMORAL AND TIBIAL COMPONENTS equivalence is claimed K070267 DEPUY GCK (SIGMA HP Partial) TIBIAL COMPONENTS K061648 DEPUY GRADUATED COMPARTMENTAL KNE… | 2007 |
| * | K061648 | Depuy Graduated Compartmental Knee (GCK)Summary page 4…l) FEMORAL AND TIBIAL COMPONENTS equivalence is claimed K070267 DEPUY GCK (SIGMA HP Partial) TIBIAL COMPONENTS K061648 DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (SIGMA HP Partial)… | 2006 |
| * | K101433 | Depuy Attune Knee SystemSummary page 4…K061648 DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (SIGMA HP Partial) K101433 DEPUY ATTUNE KNEE SYSTEM Page 1 of 5… | 2010 |
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 26 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 19 ancestors have a recall of any class.
- 3 other devices also cite its predicate K070849.
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. 2020, 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?
INDICATIONS
The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral articular surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193549 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193549: SIGMA High Performance (HP) Partial Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193549
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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