510(k) · Cleared
Recalled · Class II · 2017Zimmer Patellofemoral Joint Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jun 7, 2007 as substantially equivalent to K052917 (Howmedica Osteonics Corp., 2005) and 2 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1995. 122 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 7, 2007
- Review
- 86 days
- Class
- Class II
- Product code
- KRR
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K933785 (1995). 6 ancestors in all. 122 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 2 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 1 generation backK060370 Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc. · 2006 · Recalled
- This deviceK070695 Zimmer Patellofemoral Joint ProsthesisZimmer, Inc. · 2007
- Descendant · cites it directly · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 59 of its ownK121771 Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014
- Descendant · 3 generations on · 25 of its ownK122765 Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · Recalled
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · cites it directly117descendants
- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · 2 generations on96descendants
- K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc. · 2012 · 3 generations on59descendants
- K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 3 generations on26descendants
- K122765Persona Natural Tibia BaseplatesZimmer, Inc. · 2012 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −2 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −1 | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral Components | Zimmer, Inc. | 2006 | 17 |
| 0 (this device) | K070695 | Zimmer Patellofemoral Joint Prosthesis | Zimmer, Inc. | 2007 | — |
| +1 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| +2 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| +3 | K121771 | Zimmer Persona the Personalized Knee System | Zimmer, Inc. | 2012 | 2 |
| +3 | K140833 | Itotal Posterior Stabilized (PS) Knee Replacement System | Conformis, Inc. | 2014 | — |
| +3 | K122765 | Persona Natural Tibia Baseplates | Zimmer, Inc. | 2012 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 12 | 0 |
| 2021 | 14 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 11 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 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 KRR? 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 KRR device
- #1 K231253 Overture Orthopaedics Patellofemoral Systemscore 5.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K052917 | Stryker Compartmental Knee SystemSummary page 1…21 CER §888.3540 Predicate Device: Stryker Compartmental Knee System, manufactured by Howmedica Osteonics Corp., K0529 17, cleared December 27, 2005 Natural-Knee®oII Patellofem… | 2005 |
| * | K002356 | Natural-Knee II Patellofemoral Joint ProsthesisSummary page 1…ember 27, 2005 Natural-Knee®oII Patellofemoral Joint Prosthesis, manufactured by Zimmer, Inc., K002356, cleared October 30, 2000 NexGen®oKnee Gender Solution… | 2000 |
| * | K060370 | Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsSummary page 1…NexGen®oKnee Gender Solutions Female Femoral Components, manufactured by Zimmer, Inc., K0603 70, cleared April 28, 2006 Device Description: The Zimmer Patellofemoral Joint (PFJ) Prosthesis is… | 2006 |
What descends from it? (122)
See all 1223 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-1052-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Nov 29, 2017 | Class II | Z-1053-2018 | Packaging | The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag. |
| Jan 11, 2016 | Class II | Z-0837-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
| Jul 30, 2014 | Class II | Z-2545-2014 | Nonconforming Material/Component | Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing… |
| Aug 30, 2013 | Class II | Z-0077-2014 | Package design/selection | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 5 of the 6 ancestors have a recall of any class.
- Of its descendants, K073286 (Zimmer, Inc., 2008) has gone furthest, with 117 descendants of its own.
- 4 other devices also cite its predicate K052917.
How does its category compare?
All KRR devicesKRR Prosthesis, Knee, Patello/Femoral, 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 · KRR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KRR
116in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRR
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRR
36in 2025
MAUDE reports naming product code KRR, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 116 | 0 | 0 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 9 |
| 2013 | 1 | — | 1 | 9 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 1 | — | 1 | 14 |
| 2017 | 0 | — | 2 | 15 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 3 | 9 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
-Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint;
-The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation),
-History of patellar dislocation or patella fracture;
-Dysplasia-induced degeneration
This device is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070695: Zimmer Patellofemoral Joint Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070695
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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