# PML: Bone Cement, Posterior Screw Augmentation

- Device class: 2; regulation: 21 CFR 888.3027; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 94 days (middle half 69–119)
- Recalls: 2 (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)
- 2016: 2
- 2017: 1
- 2018: 2
- 2019: 2
- 2020: 3
- 2021: 1
- 2022: 2
- 2023: 3
- 2024: 1
- 2026: 2

## Most-cited predicates
- K152604: KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (2016), cited by 13
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems (2016), cited by 11
- K200596: G21 Cement, VADER® Pedicle System (2020), cited by 7
- K191148: Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set (2019), cited by 5
- K171938: KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set (2017), cited by 4
- K201362: CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement (2020), cited by 3
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), cited by 3
- K180498: NuVasive Reline Fenestrated Screws, High V+ Bone Cement (2018), cited by 3
- K241034: Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (2024), cited by 2
- K192818: Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System (2020), cited by 2

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