# K030724: Alumina Ceramic Femoral Heads, 28 and 32 MM

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jun 3, 2003 after 88 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905739 (1991). 2 ancestors in all.
91 later devices descend from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905739: Zimmer Ceramic Femoral Heads, Zimmer, Inc. (1991) Summary page 1.
- K914676: Zimmer (R) Ceramic Femoral Heads 28MM Diameter, Zimmer, Inc. (1992) Summary page 1.

## Most influential descendants
- K060918: Excia Total Hip System 12/14 Trunnion with Ceramic Head (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K062684: Excia Total Hip System 36MM Ceramic Head (2006), 65 descendants of its own
- K082991: Biolox Delta Ceramic Femoral Head (2008), 63 descendants of its own
- K083495: Modification to: Metha Hip System (2009), 59 descendants of its own

## Recalls of this device
- May 29, 2009 · Not classified · Z-1616-2009: The corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.
- Jun 11, 2008 · Not classified · Z-0300-2009: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
- Jun 11, 2008 · Not classified · Z-0303-2009: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
- Jun 11, 2008 · Not classified · Z-0301-2009: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
- Jun 11, 2008 · Not classified · Z-0304-2009: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
- Jun 11, 2008 · Not classified · Z-0299-2009: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
- Jun 11, 2008 · Not classified · Z-0302-2009: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.

## Indications for use
The Alumina Ceramic Femoral Heads are modular components designed for use in total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses andor total hip components in the operative extremity; and patients with acute neck fractures.

Source page: https://510kreport.com/device/K030724
Methodology: https://510kreport.com/methodology