510(k) · Cleared
Recalled · Class II · 2017Depuy Graduated Compartmental Knee (GCK)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 11, 2006 as substantially equivalent to K052917 (Howmedica Osteonics Corp., 2005) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1994. 61 later devices descend from it. It has been recalled once.
- Decided
- Sep 11, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K943462 (1994). 8 ancestors in all. 61 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 2 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 1 generation backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- This deviceK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 59 of its ownK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 51 of its ownK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- Descendant · 2 generations on · 50 of its ownK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- Descendant · 3 generations on · 26 of its ownK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- Descendant · 4 generations on · 25 of its ownK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K070849Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007 · cites it directly59descendants
- K082172Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · cites it directly51descendants
- K090763Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · 2 generations on50descendants
- K133039Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013 · 3 generations on26descendants
- K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −2 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −1 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| 0 (this device) | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| +2 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| +3 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| +4 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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 NPJ? 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 |
|---|---|---|---|
| * | K052917 | Stryker Compartmental Knee SystemSummary page 1…NPJ, HRY, KRR SUBSTANTIALLY EQUIVALENT Stryker Compartmental Knee System DEVICES: (K052917) Preservation® Unicondylar Knee System… | 2005 |
| * | K010810 | Depuy Preservation Unicondylar Knee ProsthesisSummary page 1…(K052917) Preservation® Unicondylar Knee System (K010810) PFC Sigma® Knee System (K94346… | 2001 |
| * | K943462 | Darwin Knee SystemSummary page 1…(K010810) PFC Sigma® Knee System (K943462) DePuy Sigma XLK Tibial Inserts… | 1994 |
| * | K040166 | Depuy Sigma XLK Tibial InsertsSummary page 1…(K943462) DePuy Sigma XLK Tibial Inserts (K040166) DEVICE DESCRIPTION: The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unic… | 2004 |
What descends from it? (61)
See all 616 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070849 | Depuy GCK Femoral and Tibial Components | 2007 | 59 |
| K082172 | Mako Modular Knee Compartmental Implant System | 2008 | 51 |
| K070267 | Depuy GCK Tibial Components | 2007 | 12 |
| K093056 | Smith & Nephew, Inc. Journey Select Knee System | 2009 | 9 |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System… | 2024 | 0 |
| K193549 | SIGMA High Performance (HP) Partial Knee System | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2017 | Class II | Z-1219-2018 | Under Investigation by firm | The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K070849 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 59 descendants of its own.
- 4 other devices also cite its predicate K052917.
How does its category compare?
All NPJ devicesNPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NPJ
76in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPJ
47in 2025
MAUDE reports naming product code NPJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 3 | 76 | 0 | 3 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 0 | — | 0 | 72 |
| 2013 | 1 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 1 | — | 3 | 55 |
| 2016 | 0 | — | 1 | 93 |
| 2017 | 0 | — | 0 | 150 |
| 2018 | 0 | — | 0 | 141 |
| 2019 | 0 | — | 0 | 91 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 51 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The GCK 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 GCK components are intended for CEMENTED USE ONLY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061648 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061648: Depuy Graduated Compartmental Knee (GCK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061648
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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