# K233724: 28mm/38D MDM X3 Insert for MDM Liner

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Mar 11, 2024 after 111 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). 173 ancestors in all.
No later device cites it as a predicate yet.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2019) Summary page 5.
- K161190: G7 Dual Mobility System, Active Articulation System, Biomet, Inc. (2016) Summary page 5.

## Indications for use
The indications for use for total hip arthroplasty include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and, 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 MOM Liners are intended for cementless use only.

Source page: https://510kreport.com/device/K233724
Methodology: https://510kreport.com/methodology