510(k) · Cleared
Recalled · Class II · 2026Stryker Compartmental Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 27, 2005 after a 71-day review. The FDA summary names no predicate by number. 178 later devices descend from it. It has been recalled 8 times.
- Decided
- Dec 27, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- 8
- Predicates
- 0
178 later devices descend from it, 5 citing it directly.
- This deviceK052917 Stryker Compartmental Knee SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 122 of its ownK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · cites it directly · 61 of its ownK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
Showing 5 of 178 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 178 · See all- K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007 · cites it directly122descendants
- K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · 2 generations on117descendants
- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · 3 generations on96descendants
- K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · cites it directly61descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052917 | Stryker Compartmental Knee System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K070695 | Zimmer Patellofemoral Joint Prosthesis | Zimmer, Inc. | 2007 | 5 |
| +2 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| +3 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| +1 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| +4 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 15 | 0 |
| 2020 | 18 | 0 |
| 2021 | 19 | 0 |
| 2022 | 9 | 0 |
| 2023 | 12 | 0 |
| 2024 | 18 | 0 |
| 2025 | 14 | 0 |
| 2026 | 12 | 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?
The FDA summary names no predicate by number.
What descends from it? (178)
See all 1785 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070695 | Zimmer Patellofemoral Joint Prosthesis | 2007 | 122 |
| K061648 | Depuy Graduated Compartmental Knee (GCK) | 2006 | 61 |
| K082172 | Mako Modular Knee Compartmental Implant System | 2008 | 51 |
| K093056 | Smith & Nephew, Inc. Journey Select Knee System | 2009 | 9 |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | 2016 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class II | Z-3206-2026 | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading… |
| Dec 1, 2023 | Class II | Z-0893-2024 | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Dec 1, 2023 | Class II | Z-0895-2024 | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Dec 1, 2023 | Class II | Z-0896-2024 | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Dec 1, 2023 | Class II | Z-0897-2024 | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Dec 1, 2023 | Class II | Z-0900-2024 | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Dec 1, 2023 | Class II | Z-0894-2024 | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Aug 17, 2011 | Not classified | Z-0606-2012 | Other | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070695 (Zimmer, Inc., 2007) has gone furthest, with 122 descendants of its own.
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 Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of…
Read the full statement (192 words)
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the tollowing conditions:
* Degenerative arthritis in the distal femur and patella,
* Patients with a history of patellar dislocation or patella fracture,
* Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
* Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis,
* Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis,
* As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or
Vhere bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are single use only and are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052917: Stryker Compartmental 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/K052917
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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