510(k) Report

510(k) · Cleared

Cleared

Exatech MCS Porous Coated Total Hip Femoral Stem

K921113510(k) TraditionalCleared Oct 27, 1993597-day reviewClass II21 CFR 888.3358

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

Exactech, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Oct 27, 1993 after a 597-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 148 later devices descend from it.

Decided
Oct 27, 1993
Review
597 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2000: 1 descendant cleared2003: 1 descendant cleared2004: 2 descendants cleared2008: 1 descendant cleared2013: 5 descendants cleared2012: 6 descendants cleared2005: 2 descendants cleared2010: 5 descendants cleared2006: 1 descendant cleared2014: 8 descendants cleared2009: 1 descendant cleared2018: 7 descendants cleared2007: 1 descendant cleared2016: 6 descendants cleared2015: 5 descendants cleared2017: 8 descendants cleared2019: 14 descendants cleared2026: 13 descendants cleared2020: 6 descendants cleared2023: 13 descendants cleared2025: 12 descendants cleared2024: 12 descendants cleared2022: 11 descendants cleared2021: 7 descendants cleared1990200020102020
  1. This deviceK921113 Exatech MCS Porous Coated Total Hip Femoral StemExactech, Inc. · 1993
  2. Descendant · cites it directly · 147 of its ownK002141 Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit…Exactech, Inc. · 2000
  3. Descendant · cites it directly · 146 of its ownK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
  4. Descendant · 2 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
  5. Descendant · 3 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
  6. Descendant · 3 generations on · 60 of its ownK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled

Showing 5 of 148 descendants. See all descendants

Descendants cleared per year

2000: 12003: 12004: 22005: 22006: 12007: 12008: 12009: 12010: 52012: 62013: 52014: 82015: 52016: 62017: 82018: 72019: 142020: 62021: 72022: 112023: 132024: 122025: 122026: 13
2000high 14 (2019) · low 0 (2001)2026

Most influential descendants

Showing 5 of 148 · See all
  • K002141Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series…Exactech, Inc. · 2000 · cites it directly147descendants
  • K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003 · cites it directly146descendants
  • K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · 2 generations on145descendants
  • K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 3 generations on64descendants
  • K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · 3 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921113Exatech MCS Porous Coated Total Hip Femoral StemExactech, Inc.1993—
+1K002141Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch…Exactech, Inc.2000—
+1K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003—
+2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041
+3K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.2004—
+3K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc.200512

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200310
200420
200520
200610
200710
200810
200910
201050
201260
201350
201480
201550
201660
201780
201870
2019140
202060
202170
2022110
2023130
2024120
2025120
2026130
FIG. 1 — Lineage of K921113, 1993–2026Source: 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 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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (148)

See all 148

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

NumberDeviceApplicantDecidedDescendants
K002141Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series…Exactech, Inc.2000147
K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003146

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, K002141 (Exactech, Inc., 2000) has gone furthest, with 147 descendants of its own.

How does its category compare?

All LPH devices

LPH 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

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • 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 LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K921113 · printed Nov 4, 2026

Cite this page

510(k) Report. “K921113: Exatech MCS Porous Coated Total Hip Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921113

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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