# K111981: Tregor Dual Mobility Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Aston Medical
- Decided: Oct 12, 2012 after 458 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: 9 generations back to K810258 (1981). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 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 4.
- K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 1.
- K083116: Versafit Cup Double Mobility System, Medacta International S.A. (2009) Summary page 4.
- K101336: E1 Avantage Head, Biomet Manufacturing Corp (2011) Summary page 2.
- (no number) Charnley acetabular cup: named in the summary without a submission number

## Indications for use
The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR): * Non inflammatory or rheumatoid arthritis; * Osteonecrosis of femoral head; * Hip deformity affecting its function; * Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques; * Revision of previous hip surgery; * Dislocation risks (e.g., ASA score : 3) The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. Method of fixation: When used with the TREGOR® Standard acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. When used with the TREGOR® with Blades acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® with Blades acetabular cup has blades for additional fixation. When used with the TREGOR® + acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® + acetabular cup has blades and screws for additional fixation. When used with the TREGOR® Tripod acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® Tripod acetabular cup has pegs and screw for additional fixation. When used with the TREGOR® Medial Cup acetabular cup, the TREGOR® Dual Mobility Acetabular System is for cemented use only. An optional acetabular reinforcement cross maybe be used with the TREGOR® Medial Cup, also for cemented use only.

Source page: https://510kreport.com/device/K111981
Methodology: https://510kreport.com/methodology