510(k) · Cleared
Recalled · Class II · 2022Exactech 12/14 Total Hip System
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 Sep 10, 2004 as substantially equivalent to K030236 (Exactech, Inc., 2003) and 4 other predicates after a 57-day review. Its family tree reaches back 4 generations to 1994. 145 later devices descend from it. It has been recalled once.
- Decided
- Sep 10, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 4 generations to K931641 (1994). 16 ancestors in all, the oldest K862234 (1986). 145 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 3 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 2 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 1 generation backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- This deviceK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004
- Descendant · cites it directly · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- Descendant · cites it directly · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 54 of its ownK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- Descendant · cites it directly · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
Showing 5 of 145 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 145 · See all- K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · cites it directly64descendants
- K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · cites it directly60descendants
- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · 2 generations on59descendants
- K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc. · 2010 · 2 generations on54descendants
- K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · cites it directly53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −3 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −2 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −1 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| 0 (this device) | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | — |
| +1 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| +1 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| +2 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| +2 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| +1 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 7 | 0 |
| 2019 | 14 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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 24.3 · 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? (6)
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 |
|---|---|---|---|
| * | K030236 | Acumatch P-Series Porous Press-Fit Femoral ComponentSummary page 2…Information on devices to which substantial equivalence is claimed: 510(k) Trade or Proprietary or Model Name Manufacturer Number K030236 AcuMatch P-Series Press-Fit Porous Femoral Stem Exactech, Inc. K002141 AcuMatch P-Series Press-Fi… | 2003 |
| * | K002141 | Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series…Summary page 2…or Proprietary or Model Name Manufacturer Number K030236 AcuMatch P-Series Press-Fit Porous Femoral Stem Exactech, Inc. K002141 AcuMatch P-Series Press-Fit Plasma Femoral Stem Exactech, Inc. AcuMatch L-Series Press-Fi… | 2000 |
| * | K862234 | Exactech Total Hip SystemSummary page 2…Exactech, Inc. K002141 AcuMatch P-Series Press-Fit Plasma Femoral Stem Exactech, Inc. AcuMatch L-Series Press-Fit Femoral Stem K862234 Exactech CoCr Femoral Head Exactech, Inc. K964262 Exactech CoCr Femoral Head… | 1986 |
| * | K964262 | Exactech Total Hip Systme: 22MM Femoral HeadSummary page 2…Exactech, Inc. AcuMatch L-Series Press-Fit Femoral Stem K862234 Exactech CoCr Femoral Head Exactech, Inc. K964262 Exactech CoCr Femoral Head Exactech, Inc. K993082 AcuMatch A-Series Acetabul… | 1996 |
| * | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentSummary page 2…xactech CoCr Femoral Head Exactech, Inc. K964262 Exactech CoCr Femoral Head Exactech, Inc. K993082 AcuMatch A-Series Acetabular Liners Exactech, Inc. INDICATIONS All Exactech Hip Systems are i… | 1999 |
| * | — | AcuMatch L-Series Press-Fit Femoral Stem Named without a submission number | |
| † | K000242 | Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum… | 2000 |
What descends from it? (145)
See all 1457 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042842 | Novation 12/14 Press-Fit Femoral Stem | 2004 | 64 |
| K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | 2005 | 60 |
| K112802 | Pipeline Total Hip System | 2012 | 53 |
| K080980 | Exactech Novation Element Press-Fit Femoral Stems | 2008 | 28 |
| K121392 | Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 Degree | 2013 | 4 |
| K094045 | Modificaiton to: Cardo Medical Hip System | 2010 | 1 |
| K051335 | Acumatch 12/14 Press-Fit Femoral Stems | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2022 | Class II | Z-1727-2022 | Process control | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K042842 (Exactech, Inc., 2004) has gone furthest, with 64 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 determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing…
Read the full statement (143 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.
AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.
AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation.
Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041906: Exactech 12/14 Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041906
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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