510(k) Report

510(k) · Cleared

Cleared

Exactech Tapered Wedge Femoral Stem

K140674510(k) TraditionalCleared Jun 30, 2014104-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 Jun 30, 2014 as substantially equivalent to K120578 (Howmedica Osteonics, 2012) and 3 other predicates after a 104-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.

Decided
Jun 30, 2014
Review
104 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K931641 (1994). 40 ancestors in all, the oldest K862234 (1986). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 2 other ancestors2010: 1 other ancestor2002: 3 other ancestors2000: 4 other ancestors1999: 3 other ancestors1998: 1 other ancestor1997: 2 other ancestors1996: 5 other ancestors1995: 4 other ancestors1994: 5 other ancestors1986: 1 other ancestor1993: 2 other ancestors2023: 1 descendant clearedK931641 · Porocoat Porous Coating · Depuy, Inc. · 1994K003800 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K012364 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K030236 · Acumatch P-Series Porous Press-Fit Femoral Component · Exactech, Inc. · 2003×2: 2 generations cleared close together, K041906 (2004), K042842 (2004) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 11 other ancestors4 generations back: 14 other ancestors5 generations back: 1 other ancestor 1 generation forward: 1 descendant K042842 · Novation 12/14 Press-Fit Femoral Stem · Exactech, Inc. · 2004K041906 · Exactech 12/14 Total Hip System · Exactech, Inc. · 2004 · recalledK030236 · Acumatch P-Series Porous Press-Fit Femoral Component · Exactech, Inc. · 2003K012364 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K003800 · Aml Hip Prosthesis · DePuy Orthopaedics, Inc. · 2001K931641 · Porocoat Porous Coating · Depuy, Inc. · 1994−50
  1. Root · 6 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 5 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  3. 4 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  4. 3 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
  5. 2 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
  6. 1 generation backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
  7. This deviceK140674 Exactech Tapered Wedge Femoral StemExactech, Inc. · 2014
  8. Descendant · cites it directly · 0 of its ownK221323 Exactech® Alteon® Short Tapered WedgeExactech, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K931641Porocoat Porous CoatingDepuy, Inc.1994—
−5K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−4K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−3K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003—
−2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041
−1K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.2004—
0 (this device)K140674Exactech Tapered Wedge Femoral StemExactech, Inc.2014—
+1K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199320
199450
199540
199650
199720
199810
199930
200040
200230
201010
201120
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K140674, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*K120578Accolade II Hip Stem
Summary page 2
…edge Femnoral Stem Traditional 510(k) Legally Marketed Device to Which Substantial Equivalence Is Claimed: * Accolade 11 Hip Stem (K120578) from Howmedica Osteonics Corp. (a subsidiary of Stryker Corporation) * Taperloc Complete (K101086, and K103755 - line…
Howmedica Osteonics20121
*K101086Taperloc Complete
Summary page 2
…bstantial Equivalence Is Claimed: * Accolade 11 Hip Stem (K120578) from Howmedica Osteonics Corp. (a subsidiary of Stryker Corporation) * Taperloc Complete (K101086, and K103755 - line extension to devices cleared in -*K10 1086) from Biomet Inc. * Novation 12/14 Press-Fit Femoral Stem…
Biomet, Inc.2010—
*K103755Taperloc Complete, Size 5 and 6
Summary page 2
…ivalence Is Claimed: * Accolade 11 Hip Stem (K120578) from Howmedica Osteonics Corp. (a subsidiary of Stryker Corporation) * Taperloc Complete (K101086, and K103755 - line extension to devices cleared in -*K10 1086) from Biomet Inc. * Novation 12/14 Press-Fit Femoral Stems (K(042842)…
Biomet Manufacturing Corp2011—
*K042842Novation 12/14 Press-Fit Femoral Stem
Summary page 2
…on) * Taperloc Complete (K101086, and K103755 - line extension to devices cleared in -*K10 1086) from Biomet Inc. * Novation 12/14 Press-Fit Femoral Stems (K(042842) from Exactech Inc. Device Description Exactech Tapered Wedge Femoral Stem is a collarless, press-fit prosthesis featuring a 12…
Exactech, Inc.2004—

Also cleared against K120578: 8 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K221323Exactech® Alteon® Short Tapered WedgeExactech, Inc.20230

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 20 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 15 of the 40 ancestors have a recall of any class.
  • Of its descendants, K221323 (Exactech, Inc., 2023) has gone furthest, with 0 descendants of its own.
  • 8 other devices also cite its predicate K120578.

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. 2014, this device’s year, is highlighted.

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…

Read the full statement (123 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.

* Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.

* Press-fit femoral stems and acetabular cups are intended for press-fit fixation.

* Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Indications for use as stated in the FDA summary.

Also cleared against K120578

8 other devices cite the same predicate.

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2019
  • K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation · 2016
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugCorentec Co., Ltd. · 20161 recall
  • K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct…Stryker Orthopaedics · 20152 recalls

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/K140674 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140674: Exactech Tapered Wedge Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140674

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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