510(k) · Cleared
Recalled · 2009Alumina Ceramic Femoral Heads, 28 and 32 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 3, 2003 as substantially equivalent to K905739 (Zimmer, Inc., 1991) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1991. 91 later devices descend from it. It has been recalled 7 times.
- Decided
- Jun 3, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905739 (1991). 2 ancestors in all. 91 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK905739 Zimmer Ceramic Femoral HeadsZimmer, Inc. · 1991
- This deviceK030724 Alumina Ceramic Femoral Heads, 28 and 32 MMZimmer, Inc. · 2003
- Descendant · cites it directly · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- Descendant · 2 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- Descendant · 2 generations on · 65 of its ownK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- Descendant · 2 generations on · 63 of its ownK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- Descendant · 3 generations on · 59 of its ownK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · cites it directly90descendants
- K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 2 generations on83descendants
- K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006 · 2 generations on65descendants
- K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008 · 2 generations on63descendants
- K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · 3 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905739 | Zimmer Ceramic Femoral Heads | Zimmer, Inc. | 1991 | — |
| 0 (this device) | K030724 | Alumina Ceramic Femoral Heads, 28 and 32 MM | Zimmer, Inc. | 2003 | — |
| +1 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| +2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| +2 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| +2 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| +3 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K905739 | Zimmer Ceramic Femoral HeadsSummary page 1…ted or nonporous uncemented prosthesis 21 CFR 3 888.3353 Predicate Devices: Zimmer Ceramic Femoral Heads, K905739 and K9 14676, cleared March 7, I99 1, and January 13,… | 1991 |
| * | K914676 | Zimmer (R) Ceramic Femoral Heads 28MM DiameterSummary page 1…21 CFR 3 888.3353 Predicate Devices: Zimmer Ceramic Femoral Heads, K905739 and K9 14676, cleared March 7, I99 1, and January 13, 1992, respectively. Device Description:… | 1992 |
What descends from it? (91)
See all 911 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | 2006 | 90 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2009 | Not classified | Z-1616-2009 | Packaging process control | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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 | Device Design | 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. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K060918 (Aesculap, Inc., 2006) has gone furthest, with 90 descendants of its own.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030724: Alumina Ceramic Femoral Heads, 28 and 32 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030724
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026