# KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

- Device class: 2; regulation: 21 CFR 888.3360; FDA's rule: 510(k) required
- FDA decisions: 108
- 510(k) review time 2021–2025: median 51 days (middle half 32–57)
- Recalls: 47 (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)
- 2011: 2
- 2012: 1
- 2015: 1
- 2018: 2
- 2019: 1
- 2020: 1
- 2022: 1
- 2024: 1
- 2025: 3
- 2026: 2

## Most-cited predicates
- K112470: 2GC Hip/Knee Modular Spacer (2012), cited by 8
- K172906: REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (2018), cited by 6
- K800207: Uhr UNIVERSAL6HIP Replacement (1980), cited by 6
- K965156: Ultima*Unipolar Head and Adapter Sleeves (1997), cited by 5
- K031841: Spacer G Temporary Hip Prosthesis (2004), cited by 5
- K902365: Modular Unipolar System (1991), cited by 4
- K934353: Zirconium Alloy Uni-Polar Head (1994), cited by 3
- K101356: Spacer-G and Spacer-K (2011), cited by 3
- K191981: REMEDY Acetabular Cup (2019), cited by 3
- K062408: Smith & Nephew Modular Femoral (Hemi) Head (2006), cited by 3

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