# K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model

- Pathway: 510(k) (Traditional)
- Applicant: Serf
- Decided: Aug 29, 2011 after 84 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991990 (1999). 3 ancestors in all.
27 later devices descend from it; 10 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070278: Polarcup Dual Mobility System, Plus Orthopedics AG (2007) Summary page 2.
- K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 2.
- K991990: Tri-Polar System, Biomet, Inc. (1999) Summary page 2.

## Most influential descendants
- K181744: BI-MENTUM dual mobility system (2018), 10 descendants of its own
- K203532: BI-MENTUM™ ALTRX® Dual Mobility Liner (2021), 6 descendants of its own
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K171273: LINK® BiMobile (TM) Dual Mobility System (2018), 4 descendants of its own
- K191831: MobiliT Cup (2020), 3 descendants of its own

## Recalls of this device
- Dec 21, 2020 · Class II · Z-0920-2021: Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
- Dec 21, 2020 · Class II · Z-0921-2021: Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
- Dec 21, 2020 · Class II · Z-0922-2021: Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
- Jul 23, 2019 · Class II · Z-2479-2019: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- Jul 23, 2019 · Class II · Z-2480-2019: Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

## Indications for use
NOVAE® Dual mobility Acetabular Cup is 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 are intended for press-fit use and NOVAE STICK is indicated for cemented use.

Source page: https://510kreport.com/device/K111572
Methodology: https://510kreport.com/methodology