# K181491: Delta Dual Mobility System

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: May 9, 2019 after 337 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: 12 generations back to K810258 (1981). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 5.
- K161190: G7 Dual Mobility System, Active Articulation System, Biomet, Inc. (2016) Summary page 5.
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 5.
- K112556: Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts, Howmedica Osteonics Corp. (2011) Summary page 5.
- K112898: Delta TT Cups, Delta TT Liners, Bone Screws, Lima Corporate S.P.A. (2012) Summary page 4.
- K141395: Delta TT Acetabular System, Lima Corporate S.P.A. (2014) Summary page 4.
- K070278: Polarcup Dual Mobility System, Plus Orthopedics AG (2007) Summary page 5.
- K110135: Polarcup Dual Mobility System, Smith & Nephew, Inc. (2011) Summary page 5.
- K122244: Polarcup Dual Mobility System, Smith & Nephew, Inc. (2012) Summary page 5.
- K023357: Arcpm 1050 Resin-Hips, Biomet Orthopedics, Inc. (2002) Summary page 5.
- K032396: Ringloc 36MM Line and Modular Femoral Heads, Biomet, Inc. (2003) Summary page 5.
- K042051: Arcomxl Polyethylene Liners, Biomet, Inc. (2005) Summary page 5.
- K070369: Regenerx Ringloc + Modular Acetabular Shells, Biomet, Inc. (2007) Summary page 5.

## Indications for use
The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; • Rheumatoid arthritis; • Post-traumatic arthritis, • Correction of functional deformity; • Fractures, dislocation of the hip and unsuccessful cup arthroplasty. • Revisions in cases of good remaining bone stock. Delta TT cup is intended for cementless use. The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System.

Source page: https://510kreport.com/device/K181491
Methodology: https://510kreport.com/methodology