# K103233: Modular Dual Mobility Liner, X3 Acetabular Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 3, 2011 after 93 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010170 (2001). 3 ancestors in all.
52 later devices descend from it; 11 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 2.
- K093644: Restoration Adm System X3 Acetabular, Howmedica Osteonics Corp. (2009) Summary page 2.
- K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001)

## Most influential descendants
- K150522: G7 Dual Mobility System (2015), 21 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K170359: Trinity™ Dual Mobility System (2017), 10 descendants of its own
- K112556: Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts (2011), 10 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own

## Recalls of this device
- Jun 3, 2011 · Not classified · Z-0192-2012: Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.

## Indications for use
The indications for use of the total hip arthroplasty include: 1) Noninflammatory degenerative joint disease including osteoarthiritis and avascular necrosis; 2) Rheumatoid arthritis 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. 6) Dislocation risks The MDMTM1 liners are intended for cementless use only.

Source page: https://510kreport.com/device/K103233
Methodology: https://510kreport.com/methodology