510(k) · Cleared
ClearedAcumatch P-Series Porous Press-Fit Femoral Component
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 Feb 20, 2003 as substantially equivalent to K002141 (Exactech, Inc., 2000) and 6 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1994. 146 later devices descend from it.
- Decided
- Feb 20, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K931641 (1994). 9 ancestors in all, the oldest K921113 (1993). 146 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 2 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 1 generation backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- This deviceK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- Descendant · cites it directly · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- Descendant · 2 generations on · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 54 of its ownK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
Showing 5 of 146 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 146 · See all- K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · cites it directly145descendants
- K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 2 generations on64descendants
- K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · 2 generations on60descendants
- K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · 3 generations on59descendants
- K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc. · 2010 · 3 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −2 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −1 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| 0 (this device) | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| +1 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| +2 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| +2 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| +3 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| +3 | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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 24.2 · 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? (7)
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 |
|---|---|---|---|
| * | K002141 | Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series… | 2000 |
| * | K921113 | Exatech MCS Porous Coated Total Hip Femoral StemSummary page 2…rer 5 1O(k) Number AcuMatch P-Series Plasma Exactech KO02 141 Femoral Stem MCS Porous Exactech K921113 Femoral Stem K990 197 AML Porous DePuY… | 1993 |
| * | K990197 | Modulus Compatible Stability (MCS)-HA Total Hip SystemSummary page 2…actech KO02 141 Femoral Stem MCS Porous Exactech K921113 Femoral Stem K990 197 AML Porous DePuY KO03800… | 1999 |
| * | K003800 | Aml Hip Prosthesis | 2001 |
| * | K012364 | Aml Hip Prosthesis | 2001 |
| * | K991485 | Synergy Porous Size 8 Hip StemSummary page 2…DePuY KO03800 KO 12364 Synergy Porous Smith & Nephew K991485 KO02996… | 1999 |
| * | K002996 | Synergy HA Coated Porous Femoral Stems | 2000 |
What descends from it? (146)
See all 1461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041906 | Exactech 12/14 Total Hip System | 2004 | 145 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K041906 (Exactech, Inc., 2004) has gone furthest, with 145 descendants of its own.
- 1 other device also cites its predicate K002141.
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 (107 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 Press-Fit components are intended for use in press-fit applications. Components without the optional hydroxyapatite (HA) coating may also be used with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030236: Acumatch P-Series Porous Press-Fit Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030236
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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