# K052888: Porous Titanium Acetabular Augments

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Dec 6, 2005 after 54 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001471 (2000). 1 ancestor in all.
54 later devices descend from it; 1 cites 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)
- K001471: The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ, Implex Corp. (2000) Summary page 1.

## Most influential descendants
- K100391: Depuy Universal Gription TF Cones (2010), 53 descendants of its own
- K143393: Triathlon Tritanium Cone Augments (2015), 40 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own

## Indications for use
The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies. The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use. The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.

Source page: https://510kreport.com/device/K052888
Methodology: https://510kreport.com/methodology