# K070695: Zimmer Patellofemoral Joint Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jun 7, 2007 after 86 days
- Product code: KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3540
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933785 (1995). 6 ancestors in all.
122 later devices descend from it; 3 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052917: Stryker Compartmental Knee System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K002356: Natural-Knee II Patellofemoral Joint Prosthesis, Sulzer Orthopedics, Inc. (2000) Summary page 1.
- K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components, Zimmer, Inc. (2006) Summary page 1.

## Most influential descendants
- K073286: Gender Solutions Natural-Knee Flex System (2008), 117 descendants of its own
- K113369: Zimmer Persona Knee System (2012), 96 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K122765: Persona Natural Tibia Baseplates (2012), 25 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1052-2018: 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 fro
- Nov 29, 2017 · Class II · Z-1053-2018: 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 fro
- Jan 11, 2016 · Class II · Z-0837-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Jul 30, 2014 · Class II · Z-2545-2014: 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 subs
- Aug 30, 2013 · Class II · Z-0077-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

## Indications for use
-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.

Source page: https://510kreport.com/device/K070695
Methodology: https://510kreport.com/methodology