# OQG: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

- Device class: 2; regulation: 21 CFR 888.3358; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 233 days (middle half 181–286)
- 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)
- 2011: 1
- 2012: 5
- 2013: 3
- 2014: 3
- 2015: 1
- 2017: 3
- 2020: 2
- 2021: 2

## Most-cited predicates
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM (2011), cited by 10
- K130365: X-Alt Highly Cross Linked VE Acetabular Liner (2013), cited by 7
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (2012), cited by 7
- K112802: Pipeline Total Hip System (2012), cited by 6
- K141972: Klassic HD Acetabular Insert with E-Link Poly (2014), cited by 5
- K112897: Renovis Surgical Hip Joint Replacement Prosthesis (2012), cited by 4
- K122773: Cross-Over Acetabular Shell & Liner (2012), cited by 3
- K173104: Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly (2017), cited by 2
- K172651: FMP Extended Liners (2017), cited by 2
- K140130: X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded, 20 Degree Hooded (2014), cited by 1

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