# K223745: Novae® Dual Mobility System, Hype® Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Serf
- Decided: Dec 22, 2023 after 373 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K941847 (1994). 200 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181744: BI-MENTUM dual mobility system, Serf (2018) Summary page 5.
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model, Serf (2011) Summary page 5.
- K190344: DePuy Corail AMT Hip Prosthesis, Depuy (Ireland) (2019) Summary page 5.
- K123991: Depuy Corail Amt Hip Prosthesis, Depuy France S.A.S. (2013) Summary page 5.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 5.
- K082239: Depuy C-Stem Amt, DePuy Orthopaedics, Inc. (2008) Summary page 5.
- K042959: Depuy C-Stem Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2004) Summary page 5.
- K160907: DePuy Actis DuoFix Hip Prosthesis, Depuy (Ireland) (2016) Summary page 5.
- K150862: DePuy Actis Duofox Hip Prosthesis, DePuy Orthopaedics, Inc. (2015) Summary page 5.
- K980513: Articul/Eze Femoral Heads, DePuy Orthopaedics, Inc. (1998) Summary page 5.
- K011533: Depuy Femoral Heads, DePuy Orthopaedics, Inc. (2002) Summary page 5.

## Most influential descendants
- K250989: Stryker and Serf hip devices (2025), 0 descendants of its own

## Indications for use
The Novae® Dual Mobility and Hype® Hip Systems are indicated for total hip replacement, which includes: • Osteoarthritis, • Femoral neck fracture, • Dislocation risk, • Osteonecrosis of the femoral head, • Revision procedures where other treatments or devices have failed and if bone reconstruction so permits. Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use. Hype® SCS, SCC, SCL, SCV, SCC mini, and SCLA mini hip stems are intended for press-fit use.

Source page: https://510kreport.com/device/K223745
Methodology: https://510kreport.com/methodology