510(k) Report

510(k) · Cleared

Cleared

Novation 12/14 Press-Fit Femoral Stem

K042842510(k) SpecialCleared Nov 9, 200426-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 Nov 9, 2004 as substantially equivalent to K041906 (Exactech, Inc., 2004) after a 26-day review. Its family tree reaches back 5 generations to 1994. 64 later devices descend from it.

Decided
Nov 9, 2004
Review
26 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K931641 (1994). 17 ancestors in all, the oldest K862234 (1986). 64 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1999: 3 other ancestors1996: 2 other ancestors1986: 1 other ancestor1994: 2 other ancestors1993: 2 other ancestors2006: 1 descendant cleared2014: 3 descendants cleared2012: 2 descendants cleared2010: 1 descendant cleared2009: 1 descendant cleared2015: 1 descendant cleared2017: 4 descendants cleared2013: 4 descendants cleared2023: 10 descendants cleared2018: 3 descendants cleared2016: 2 descendants cleared2022: 8 descendants cleared2019: 5 descendants cleared2020: 1 descendant cleared2021: 4 descendants cleared2024: 5 descendants cleared2026: 6 descendants cleared2025: 3 descendants 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. · 2003K041906 · Exactech 12/14 Total Hip System · Exactech, Inc. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 4 other ancestors3 generations back: 7 other ancestors4 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 8 descendants3 generations forward: 12 descendants4 generations forward: 16 descendants5 generations forward: 10 descendants6 generations forward: 6 descendants7 generations forward: 6 descendants K041906 · 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+5
  1. Root · 5 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 4 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  3. 3 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
  4. 2 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
  5. 1 generation backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
  6. This deviceK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
  7. Descendant · cites it directly · 54 of its ownK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
  8. Descendant · cites it directly · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
  9. Descendant · 2 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
  10. Descendant · 3 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
  11. Descendant · 4 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 12012: 22013: 42014: 32015: 12016: 22017: 42018: 32019: 52020: 12021: 42022: 82023: 102024: 52025: 32026: 6
2006high 10 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 64 · See all
  • K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc. · 2010 · cites it directly54descendants
  • K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · cites it directly53descendants
  • K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 2 generations on21descendants
  • K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 3 generations on20descendants
  • K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 4 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K931641Porocoat Porous CoatingDepuy, Inc.1994—
−4K003800Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−3K012364Aml Hip ProsthesisDePuy Orthopaedics, Inc.2001—
−2K030236Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc.2003—
−1K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041
0 (this device)K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.2004—
+1K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma…Exactech, Inc.2010—
+1K112802Pipeline Total Hip SystemPipeline Orthopedics2012—
+2K122158PBP Total Hip SystemPipeline Biomedical Products, LLC2012—
+3K131237Pipeline Total Hip SystemPipeline Orthopedics2013—
+4K161184iNSitu Total Hip SystemTheken Companies, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199320
199420
199620
199930
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201010
201220
201340
201430
201510
201620
201740
201830
201950
202010
202140
202280
2023100
202450
202530
202660
FIG. 1 — Lineage of K042842, 1994–2026Source: 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), 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
*K041906Exactech 12/14 Total Hip System
Summary page 2
…Information on devices to which substantial equivalence is claimed: 510(k) Trade or Proprietary or Model Name Manufacturer Number #K041906 AcuMatch P-Series Plasma Press-Fit Femoral Stems Exactech, Inc. INDICATIONS FOR USE: All Exactech Hip Syst…
Exactech, Inc.20041

Also cleared against K041906: 6 other devices →

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated…Exactech, Inc.201054
K112802Pipeline Total Hip SystemPipeline Orthopedics201253
K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144
K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141
K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.20090
K063279Novation Splined RDD Femoral StemsExactech, Inc.20060

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 10 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 17 ancestors have a recall of any class.
  • Of its descendants, K102487 (Exactech, Inc., 2010) has gone furthest, with 54 descendants of its own.
  • 6 other devices also cite its predicate K041906.

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…

Read the full statement (112 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.

Novation® press-fit femnoral stems are intended for press-fit fixation.

Press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Indications for use as stated in the FDA summary.

Also cleared against K041906

6 other devices cite the same predicate.

  • K121392Novation Crown Cup Liners; Neutral, Lipped, +5MM Lateralized, +5/10 DegreeExactech, Inc. · 20137 recalls
  • K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012
  • K094045Modificaiton to: Cardo Medical Hip SystemCardo Medical Corp. · 2010
  • K080980Exactech Novation Element Press-Fit Femoral StemsExactech, Inc. · 20081 recall
  • K051556Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 200512 recalls
  • K051335Acumatch 12/14 Press-Fit Femoral StemsExactech, Inc. · 2005

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/K042842 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042842: Novation 12/14 Press-Fit 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/K042842

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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