# FWP: Prosthesis, Chin, Internal

- Device class: 2; regulation: 21 CFR 878.3550; FDA's rule: 510(k) required
- FDA decisions: 66
- 510(k) review time 2021–2025: median 89 days (middle half 89–89)
- Recalls: 1 (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)
- 2002: 2
- 2009: 1
- 2012: 1
- 2014: 1
- 2015: 1
- 2016: 2
- 2019: 2
- 2020: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla (1992), cited by 9
- K832283: Medpar Surgical Implants (1984), cited by 2
- K191130: Customized Contour Implant (2019), cited by 2
- K143173: Stryker CMF MEDPOR Customized Implant (2015), cited by 2
- K831724: Chin (Mentoplasty) Implants (1983), cited by 1
- K913761: 3-D Accuscan Facial Implants (1991), cited by 1
- K141027: 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar II Implant, Dorsal Columella Imp (2014), cited by 1
- K121315: Stryker CMF Medpor Customized Implant (2012), cited by 1
- K012350: Medpor Plus Surgical Implant Biomaterial (2002), cited by 1
- K153508: Stryker CMF MEDPOR Customized Implant (2016), cited by 1

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