# LZK: Implant, Malar

- Device class: 2; regulation: 21 CFR 878.3550; FDA's rule: 510(k) required
- FDA decisions: 40
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1991: 4
- 1992: 1
- 1994: 6
- 1995: 1
- 1996: 7
- 1997: 4
- 1998: 6
- 1999: 1
- 2000: 1
- 2002: 1

## Most-cited predicates
- K970400: Bone Source Hydroxyapatite (1997), cited by 3
- K002886: Implantech Composite Facial Implants (Malar, Chin, and Nasal) (2000), cited by 2
- K973574: Duralastic Anatomical Malar Implant (1997), cited by 1
- K983756: Surgiform Anatomical Malar (1998), cited by 1
- K961511: Hapset Hydroxylapatite Bone Graft Plaster (1996), cited by 1

Source page: https://510kreport.com/product-code/LZK
Data by year (CSV): https://510kreport.com/product-code/LZK.csv