510(k) · Cleared
ClearedDepuy GCK Tibial Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Aug 17, 2007 as substantially equivalent to K061648 (DePuy Orthopaedics, Inc., 2006) and 2 other predicates after a 200-day review. Its family tree reaches back 4 generations to 1994. 12 later devices descend from it.
- Decided
- Aug 17, 2007
- Review
- 200 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K943462 (1994). 12 ancestors in all, the oldest K910968 (1991). 12 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 3 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 2 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 1 generation backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- This deviceK070267 Depuy GCK Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK093056 Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK160738 ZUK Select Knee SystemSmith & Nephew, Inc. · 2016
- Descendant · 3 generations on · 7 of its ownK190085 Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK191211 JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K093056Smith & Nephew, Inc. Journey Select Knee SystemSmith & Nephew, Inc. · 2009 · cites it directly9descendants
- K160738ZUK Select Knee SystemSmith & Nephew, Inc. · 2016 · 2 generations on8descendants
- K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 3 generations on7descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 4 generations on3descendants
- K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −3 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −2 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −1 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| 0 (this device) | K070267 | Depuy GCK Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K093056 | Smith & Nephew, Inc. Journey Select Knee System | Smith & Nephew, Inc. | 2009 | — |
| +2 | K160738 | ZUK Select Knee System | Smith & Nephew, Inc. | 2016 | — |
| +3 | K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | 3 |
| +4 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
| +3 | K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K061648 | Depuy Graduated Compartmental Knee (GCK)Summary page 1…ed cement prosthesis, Class 1I Product Codes: HRY, NPJ Substantially Equivalent Devices: DePuy GCK (K061648) DePuy Preservation Unicondylar Knee (K(040268) DePuy Sigma… | 2006 |
| * | K040268 | Depuy Preservation Unicondylar TibiaSummary page 1…HRY, NPJ Substantially Equivalent Devices: DePuy GCK (K061648) DePuy Preservation Unicondylar Knee (K(040268) DePuy Sigma Unicompartmental Knee, submitted as the J&J PFC… | 2004 |
| * | K910968 | P.F.C. Unicondylar Knee SystemSummary page 1…Knee (K(040268) DePuy Sigma Unicompartmental Knee, submitted as the J&J PFC Unicondylar Knee System (K910968) Device Description: The Sigma High Performance Unity Knee Resurfacing System is composed of unicompartmental femoral components… | 1991 |
What descends from it? (12)
See all 123 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 8 of the 12 ancestors have a recall of any class.
- Of its descendants, K093056 (Smith & Nephew, Inc., 2009) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K061648.
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. 2007, 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 Sigma High Performance Unity Knee Resurfacing System is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070267: Depuy GCK Tibial Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070267
Report an extraction error
Are you the manufacturer?
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