510(k) · Cleared
Recalled · Class II · 2021Exactech Ziramic Zirconia 12/14 Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Nov 18, 2005 as substantially equivalent to K032964 (Exactech, Inc., 2003) after a 275-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 18, 2005
- Review
- 275 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993736 (2000). 5 ancestors in all, the oldest K914574 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK993736 Exactech Acumatch Integrated Hip System M-Series Femoral Stem…Exactech, Inc. · 2000 · Recalled
- 2 generations backK010120 Modification to Exactech Acumatch Integrated Hip System, M-Series…Exactech, Inc. · 2001
- 1 generation backK032964 Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series…Exactech, Inc. · 2003 · Recalled
- This deviceK050398 Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK060107 Modification to: Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc. · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K060107Modification to: Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component | Exactech, Inc. | 2000 | 1 |
| −2 | K010120 | Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set… | Exactech, Inc. | 2001 | — |
| −1 | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck… | Exactech, Inc. | 2003 | 1 |
| 0 (this device) | K050398 | Exactech Ziramic Zirconia 12/14 Femoral Heads | Exactech, Inc. | 2005 | — |
| +1 | K060107 | Modification to: Exactech Ziramic Zirconia 12/14 Femoral Heads | Exactech, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck SegmentsSummary page 2…........................ Legally Marketed Devices for Substantial Equivalence Comparison: Exactech 12/14 Alumina Ceramic Femoral Head #K032964 Device Description: INDICATIONS All Exactech Hip Systems are indicated for use in skeletally mature individuals… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060107 | Modification to: Exactech Ziramic Zirconia 12/14 Femoral Heads | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2021 | Class II | Z-2250-2021 | Under Investigation by firm | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K060107 (Exactech, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K032964.
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?
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing…
Read the full statement (168 words)
All Exactech Hip Systems are indicated for use in skeletally mature individuals
undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid
arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for
treatment of proximal femoral fractures where prosthetic replacement is determined by
the surgeon as the preferred treatment. Components of Exactech Hip Systems are also
potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of
failed previous reconstructions where sufficient bone stock is present, and to restore
mobility resulting from previous fusion.
Exactech Hip Systems are contraindicated in patients with active infection, patients
without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis,
in neuromuscular disorders that do not allow control of the hip joint, and in patients
whose weight, age, or activity level would cause the surgeon to expect early failure of the
system.
The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner
than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed
UHMWPE liner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050398: Exactech Ziramic Zirconia 12/14 Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050398
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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