510(k) · Cleared
Recalled · Class II · 2021Modification to: Exactech 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 Feb 6, 2006 as substantially equivalent to K050398 (Exactech, Inc., 2005) after a 24-day review. Its family tree reaches back 4 generations to 2000. It has been recalled once.
- Decided
- Feb 6, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993736 (2000). 6 ancestors in all, the oldest K914574 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK993736 Exactech Acumatch Integrated Hip System M-Series Femoral Stem…Exactech, Inc. · 2000 · Recalled
- 3 generations backK010120 Modification to Exactech Acumatch Integrated Hip System, M-Series…Exactech, Inc. · 2001
- 2 generations backK032964 Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series…Exactech, Inc. · 2003 · Recalled
- 1 generation backK050398 Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc. · 2005 · Recalled
- This deviceK060107 Modification to: Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component | Exactech, Inc. | 2000 | 1 |
| −3 | K010120 | Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set… | Exactech, Inc. | 2001 | — |
| −2 | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck… | Exactech, Inc. | 2003 | 1 |
| −1 | K050398 | Exactech Ziramic Zirconia 12/14 Femoral Heads | Exactech, Inc. | 2005 | 1 |
| 0 (this device) | K060107 | Modification to: Exactech Ziramic Zirconia 12/14 Femoral Heads | Exactech, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 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 |
|---|---|---|---|
| * | K050398 | Exactech Ziramic Zirconia 12/14 Femoral HeadsSummary page 2…keted Devices for Substantial Equivalence Comparison: Exactech® ZiramiCT M Zirconia 12/14 Femoral Head #K050398 Device Description: INDICATIONS All Exactech Hip Systemns are indicated for use in skeletally mature individuals… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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-2251-2021 | 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 6 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- 3 of the 6 ancestors have a recall of any class.
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 ostcoarthritis, 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 1-ip 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060107: Modification to: 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/K060107
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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