# K093644: Restoration Adm System X3 Acetabular

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 18, 2009 after 23 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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
No predicates in its family tree.
57 later devices descend from it; 7 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert (2011), 52 descendants of its own
- K101336: E1 Avantage Head (2011), 24 descendants of its own
- K110555: Arcomxl Active Articulation (2011), 22 descendants of its own
- K150522: G7 Dual Mobility System (2015), 21 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own

## Recalls of this device
- Jun 3, 2011 · Not classified · Z-0193-2012: 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 osteoarthritis 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 This acetabular cup is intended for cementless use only.

Source page: https://510kreport.com/device/K093644
Methodology: https://510kreport.com/methodology