# K052748: System 12 X3 Acetabular Inserts; Series II X3 Acetabular Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 2, 2005 after 63 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 its predicate without a number.
- (no number) System 12 and Series II Hip System Acetabular Inserts: named in the summary without a submission number

## Most influential descendants
- K103124: Series II X3 Large Diameter Accetabular Inserts (2010), 0 descendants of its own

## Indications for use
The System 12® X3M' Acetabular inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows: noninflammatory degenerative joint disease including osteoatrthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Series II X3 Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. Indications for use are as follows: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K052748
Methodology: https://510kreport.com/methodology