510(k) Report

510(k) · Cleared

Cleared

Exactech 12/14 Alumina Femoral Heads 36 MM

K051682510(k) SpecialCleared Jul 19, 200526-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. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jul 19, 2005 as substantially equivalent to K032964 (Exactech, Inc., 2003) after a 26-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.

Decided
Jul 19, 2005
Review
26 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K993736 (2000). 5 ancestors in all, the oldest K914574 (1992). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1992: 1 other ancestor2010: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant clearedK993736 · Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component · Exactech, Inc. · 2000 · recalledK010120 · Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set Neck Segment, M-Series Low Off-Set Neck S · Exactech, Inc. · 2001K032964 · Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments · Exactech, Inc. · 2003 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K032964 · Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments · Exactech, Inc. · 2003 · recalledK010120 · Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set Neck Segment, M-Series Low Off-Set Neck S · Exactech, Inc. · 2001K993736 · Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component · Exactech, Inc. · 2000 · recalled0+5
  1. Root · 3 generations backK993736 Exactech Acumatch Integrated Hip System M-Series Femoral Stem…Exactech, Inc. · 2000 · Recalled
  2. 2 generations backK010120 Modification to Exactech Acumatch Integrated Hip System, M-Series…Exactech, Inc. · 2001
  3. 1 generation backK032964 Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series…Exactech, Inc. · 2003 · Recalled
  4. This deviceK051682 Exactech 12/14 Alumina Femoral Heads 36 MMExactech, Inc. · 2005
  5. Descendant · cites it directly · 5 of its ownK103012 Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM…Exactech, Inc. · 2010
  6. Descendant · 2 generations on · 4 of its ownK121392 Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10…Exactech, Inc. · 2013 · Recalled
  7. Descendant · 3 generations on · 3 of its ownK173583 Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · Recalled
  8. Descendant · 4 generations on · 2 of its ownK182502 Alteon Acetabular Cup SystemExactech, Inc. · 2019 · Recalled
  9. Descendant · 5 generations on · 1 of its ownK210614 BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2010: 12013: 12018: 12019: 12022: 12023: 1
2010high 1 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K103012Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox…Exactech, Inc. · 2010 · cites it directly5descendants
  • K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc. · 2013 · 2 generations on4descendants
  • K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc. · 2018 · 3 generations on3descendants
  • K182502Alteon Acetabular Cup SystemExactech, Inc. · 2019 · 4 generations on2descendants
  • K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K993736Exactech Acumatch Integrated Hip System M-Series Femoral Stem ComponentExactech, Inc.20001
−2K010120Modification to Exactech Acumatch Integrated Hip System, M-Series High Off-Set…Exactech, Inc.2001—
−1K032964Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck…Exactech, Inc.20031
0 (this device)K051682Exactech 12/14 Alumina Femoral Heads 36 MMExactech, Inc.2005—
+1K103012Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD…Exactech, Inc.2010—
+2K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc.20137
+3K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.20183
+4K182502Alteon Acetabular Cup SystemExactech, Inc.20192
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201310
201810
201910
202210
202310
FIG. 1 — Lineage of K051682, 2000–2023Source: 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), 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032964Exactech 12/14 Alumina Femoral Head; Exactech Acumatch M-Series 12/14 Neck Segments
Summary page 2
…rietary or Model Name Manufacturer Number #K032964 Exactech 12/14 Alumina Femoral Heads…
Exactech, Inc.20031

Also cleared against K032964: 4 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103012Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox…Exactech, Inc.20105

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 5 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K103012 (Exactech, Inc., 2010) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K032964.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

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 spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K032964

4 other devices cite the same predicate.

  • K103012Exactech Bioloxdelta / Biolox Femoral Heads, 28MM OD, 32MM OD, 36MM OD, Exactech Biolox Option…Exactech, Inc. · 2010
  • K073337Mectacer Biolox Forte-Femoral HeadsMedacta International S.A. · 2008
  • K051858Acumatch M-Series LPB 12/14 Femoral StemExactech, Inc. · 2005
  • K050398Exactech Ziramic Zirconia 12/14 Femoral HeadsExactech, Inc. · 20051 recall

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 LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K051682 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051682: Exactech 12/14 Alumina Femoral Heads 36 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051682

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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