510(k) Report

510(k) · Cleared

Cleared

Novation CFS Press-Fit and Cemented Stems

K090764510(k) SpecialCleared Apr 21, 200929-day reviewClass II21 CFR 888.3360

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

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

Cleared on Apr 21, 2009 as substantially equivalent to K042842 (Exactech, Inc., 2004) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1994.

Decided
Apr 21, 2009
Review
29 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K931641 (1994). 24 ancestors in all, the oldest K862234 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor2000: 3 other ancestors1999: 3 other ancestors1996: 3 other ancestors1986: 1 other ancestor1994: 2 other ancestors1993: 2 other ancestorsK931641 · 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) 198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 7 other ancestors4 generations back: 8 other ancestors5 generations back: 1 other ancestor 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 deviceK090764 Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
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)K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199320
199420
199630
199930
200030
200110
200210
200510
200810
FIG. 1 — Lineage of K090764, 1994–2009Source: 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K042842Novation 12/14 Press-Fit Femoral Stem
Summary page 1
…orous, uncemented Information on devices to which Substantial equivalence is claimed: 510(k) Number Trade or Proprietary or Model Name Manufacturer K042842 Novation® 12/14 Press-Fit Femoral Stems Exactech, Inc. K083392 Novation® Cemented Plus Femoral…
Exactech, Inc.2004—
*K083392Novation 12/14 Cemented Femoral Stems
Summary page 1
…ed: 510(k) Number Trade or Proprietary or Model Name Manufacturer K042842 Novation® 12/14 Press-Fit Femoral Stems Exactech, Inc. K083392 Novation® Cemented Plus Femoral Stems Exactech, Inc. Indications for Use: All Exactech Hip Systems are i…
Exactech, Inc.20081

Also cleared against K042842: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 15 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 4 of the 24 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K042842.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—

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

* 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 K042842

5 other devices cite the same predicate.

  • K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014
  • K140674Exactech Tapered Wedge Femoral StemExactech, Inc. · 2014
  • K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012
  • K102487Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20Exactech, Inc. · 2010
  • K063279Novation Splined RDD Femoral StemsExactech, Inc. · 20062 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 LWJ

The LWJ category page

  • K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
  • K103518Trinity Acetabular SystemCorin USA · 2011
  • K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007
  • K062978U2 Hip Stem, TI Plasma SprayUnited Orthopedic Corp. · 2007

https://510kreport.com/device/K090764 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090764: Novation CFS Press-Fit and Cemented Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090764

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