510(k) · Cleared
Recalled · 2007Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 13, 2003 as substantially equivalent to K914574 (Exactech, Inc., 1992) and 3 other predicates after a 51-day review. Its family tree reaches back 2 generations to 2000. 25 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 2003
- Review
- 51 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K993736 (2000). 4 ancestors in all, the oldest K914574 (1992). 25 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK993736 Exactech Acumatch Integrated Hip System M-Series Femoral Stem…Exactech, Inc. · 2000 · Recalled
- 1 generation backK010120 Modification to Exactech Acumatch Integrated Hip System, M-Series…Exactech, Inc. · 2001
- This deviceK032964 Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series…Exactech, Inc. · 2003
- Descendant · cites it directly · 16 of its ownK073337 Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008
- Descendant · 2 generations on · 14 of its ownK112115 Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011
- Descendant · 2 generations on · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · 3 generations on · 7 of its ownK150007 Modified Bencox Hip SystemCorentec Co., Ltd. · 2015
- Descendant · 4 generations on · 6 of its ownK162127 Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K073337Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008 · cites it directly16descendants
- K112115Mectacer Biolox (R) Delta Femoral HeadsMedacta International · 2011 · 2 generations on14descendants
- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · 2 generations on8descendants
- K150007Modified Bencox Hip SystemCorentec Co., Ltd. · 2015 · 3 generations on7descendants
- K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. · 2016 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component | Exactech, Inc. | 2000 | 1 |
| −1 | K010120 | Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set… | Exactech, Inc. | 2001 | — |
| 0 (this device) | K032964 | Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck… | Exactech, Inc. | 2003 | — |
| +1 | K073337 | Mectacer Biolox Forte-Femoral Heads | Medacta International S.A. | 2008 | — |
| +2 | K112115 | Mectacer Biolox (R) Delta Femoral Heads | Medacta International | 2011 | — |
| +2 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +3 | K150007 | Modified Bencox Hip System | Corentec Co., Ltd. | 2015 | — |
| +4 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System | Corentec Co., Ltd. | 2016 | 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 |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K914574 | Exactech Ceramic Femoral Head ComponentSummary page 2…Section: 888.3358 Legally Marketed Devices for Substantial Equivalerice Comparison: Exactech Zirconia Ceramic Femoral Head #K9 145 7 4 #K93 16 17 Exactech AcuMatch M-Series Femoral Sterns… | 1992 |
| * | K931617 | Exactech Ziramic Femoral Head ComponentSummary page 2…quivalerice Comparison: Exactech Zirconia Ceramic Femoral Head #K9 145 7 4 #K93 16 17 Exactech AcuMatch M-Series Femoral Sterns (Neck Segments) #KO1 0120 rev. I0/2… | 1994 |
| * | K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem ComponentSummary page 4…ial 510(k) AcuMatch M-Series 12/14 Neck Segmeuts This Spccial 5 10(k) application supports modification of the AcuMatch M-Series neck segments (#K993736, #KO10120). Modifications were made to the femoral stem cone design, neck geometry and through-hole diameter. The… | 2000 |
| * | K010120 | Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set Neck… | 2001 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073337 | Mectacer Biolox Forte-Femoral Heads | 2008 | 16 |
| K051682 | Exactech 12/14 Alumina Femoral Heads 36 MM | 2005 | 6 |
| K103012 | Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox… | 2010 | 5 |
| K050398 | Exactech Ziramic Zirconia 12/14 Femoral Heads | 2005 | 1 |
| K051858 | Acumatch M-Series LPB 12/14 Femoral Stem | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2007 | Not classified | Z-0572-2008 | Process control | Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K073337 (Medacta International S.A., 2008) has gone furthest, with 16 descendants of its own.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
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 detemiined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing…
Read the full statement (104 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 detemiined 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.
AcuMatch M-Series 12/14 Neck Segments and Exactech 12/14 Alumina Femoral Heads are intended to be used in press-fit and cemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032964: Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032964
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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