# KWP: Appliance, Fixation, Spinal Interlaminal

- Device class: 2; regulation: 21 CFR 888.3050; FDA's rule: 510(k) required
- FDA decisions: 430
- Recalls: 51 (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)
- 2006: 9
- 2007: 14
- 2008: 13
- 2009: 12
- 2010: 14
- 2011: 12
- 2012: 18
- 2013: 12
- 2014: 13
- 2015: 9

## Most-cited predicates
- K955348: Titanium Moss Miami Spinal System (1996), cited by 34
- K041119: Expedium Spine System (2004), cited by 29
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) (2002), cited by 29
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems (1998), cited by 26
- K042508: Sumit Oct Spinal System and Mountaineer Oct Spinal System (2004), cited by 21
- K052123: Synthes Pangea System (2005), cited by 21
- K003780: Vertex Reconstruction System (2001), cited by 21
- K031175: Click'x Monoaxial Screws and Hooks (2003), cited by 20
- K013823: Xia Spinal System (2001), cited by 18
- K981676: CD Horizon Spinal System (1999), cited by 18

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