# K090897: Tritanium  Non-Modular Shell & X3 All-Poly Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 23, 2009 after 205 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Trident™ Porous Titanium Acetabular Shell: named in the summary without a submission number
- (no number) Zimmer Trabecular Metal™ Acetabular Revision System: named in the summary without a submission number
- (no number) Trident® Constrained Acetabular Insert: named in the summary without a submission number
- (no number) Trident® Large Diameter Acetabular Inserts: named in the summary without a submission number

## Indications for use
1. Noninflammatory degenerative joint disease incuding osteoarthritis and avascular necrosis; 2. Rheumatoid arthritis (excepting the OSTEOLOCK HA Acetabular Cup); 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 The Tritanium® Non-Modular Shell is intended for cementless use, while the X3® All-Poly Insert is intended for cemented use only in both primary and revision applications.

Source page: https://510kreport.com/device/K090897
Methodology: https://510kreport.com/methodology