# KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

- Device class: 2; regulation: 21 CFR 878.3500; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 59 days (middle half 59–59)
- Recalls: 5 (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)
- 2005: 2
- 2007: 1
- 2008: 1
- 2010: 1
- 2011: 1
- 2013: 1
- 2014: 3
- 2015: 1
- 2016: 2
- 2021: 1

## Most-cited predicates
- K043250: Stryker Patient Specific Polymer Implant (2005), cited by 4
- K103010: Stryker Patient Specific Polymer Implant (2010), cited by 3
- K123908: Omnipore Surgical Implants and Accessories (2013), cited by 3
- K022665: Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe (2002), cited by 3
- K080507: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant (2008), cited by 2
- K021889: Surgiform Augmentation Material (S.F.a.M.) (2002), cited by 2
- K140437: SU-Por Surgical Implant (2014), cited by 2
- K043133: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor (2005), cited by 2
- K904111: HTR Polymer, HTR-MX (1990), cited by 2
- K141880: Biopor Aoc Porous Polyethylene, Cerepor (2015), cited by 2

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