510(k) Report

510(k) · Cleared

Cleared

Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum Acetabular Component with Hydroxyapatite

K000242510(k) SpecialCleared Feb 16, 200020-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Exactech, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on Feb 16, 2000 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it.

Decided
Feb 16, 2000
Review
20 days
Class
Class II
Product code
MEH
Recalls
None
Predicates
0

62 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared2005: 1 descendant cleared2018: 4 descendants cleared2013: 1 descendant cleared2010: 2 descendants cleared2015: 3 descendants cleared2019: 8 descendants cleared2014: 4 descendants cleared2012: 2 descendants cleared2022: 4 descendants cleared2025: 5 descendants cleared2021: 3 descendants cleared2020: 3 descendants cleared2023: 3 descendants cleared2026: 8 descendants cleared2017: 2 descendants cleared2016: 1 descendant cleared2024: 6 descendants cleared200020052010201520202025
  1. This deviceK000242 Acumatch a-Series Corundum Acetabular Component and Acumatch…Exactech, Inc. · 2000
  2. Descendant · cites it directly · 61 of its ownK040613 Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
  4. Descendant · cites it directly · 59 of its ownK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
  5. Descendant · 2 generations on · 53 of its ownK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
  6. Descendant · 3 generations on · 36 of its ownK122798 Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12007: 12010: 22012: 22013: 12014: 42015: 32016: 12017: 22018: 42019: 82020: 32021: 32022: 42023: 32024: 62025: 52026: 8
2004high 8 (2019) · low 0 (2006)2026

Most influential descendants

Showing 5 of 62 · See all
  • K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc. · 2004 · cites it directly61descendants
  • K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · 2 generations on60descendants
  • K070479Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · cites it directly59descendants
  • K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010 · 2 generations on53descendants
  • K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc. · 2012 · 3 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000242Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum…Exactech, Inc.2000—
+1K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc.20041
+2K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.200512
+1K070479Exactech Novation Crown Cup and LinersExactech, Inc.200716
+2K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc.2010—
+3K122798Integrip Acetabular Shell, Integrip Revision Acetabular ShellExactech, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200710
201020
201220
201310
201440
201530
201610
201720
201840
201980
202030
202130
202240
202330
202460
202550
202680
FIG. 1 — Lineage of K000242, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MEH? 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 MEH device

  1. #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (62)

See all 62

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040613Exactech Acumatch a-Series and MCS Acetabular Shells and LinersExactech, Inc.200461
K070479Exactech Novation Crown Cup and LinersExactech, Inc.200759

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?

  • Of its descendants, K040613 (Exactech, Inc., 2004) has gone furthest, with 61 descendants of its own.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEH

5in 2025

2007: 22008: 62009: 62010: 52011: 52012: 62013: 12015: 22016: 62017: 32018: 22019: 12020: 32021: 32022: 32023: 22024: 62025: 52026 (partial year): 1
2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2008: 79 days median2009: 65 days median2010: 226 days median2011: 95 days median2012: 131 days median2016: 163 days median2017: 209 days median2020: 131 days median2021: 83 days median2022: 150 days median2024: 91 days median2025: 87 days median
2007high 226 (2010) · low 65 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MEH

1in 2025

2007: 32008: 802009: 512010: 162011: 42012: 32014: 12015: 12016: 42017: 12018: 32020: 12025: 12026 (partial year): 1
2007high 80 (2008) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MEH

470in 2025

2007: 252008: 2612009: 5392010: 4622011: 4192012: 1,6062013: 1,2952014: 1,1962015: 4902016: 3472017: 3832018: 3372019: 3352020: 3382021: 3722022: 3162023: 3342024: 3542025: 470
2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—325
200867980261
200966551539
2010522616462
20115954419
2012613131,606
20131—01,295
20140—11,196
20152—1490
201661634347
201732091383
20182—3337
20191—0335
202031311338
20213830372
202231500316
20232—0334
20246910354
20255871470
20261—1—

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

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  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

Recent decisions in MEH

The MEH category page

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  • K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
  • K251166Mfinity Femoral SystemMedacta International S.A. · 2025
  • K251052Trivicta® Hip StemOrtho Development Corp. · 2025
  • K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025

https://510kreport.com/device/K000242 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000242: Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum Acetabular Component with Hydroxyapatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000242

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026