510(k) · Cleared
Recalled · Class II · 2016Novation 12/14 Cemented Femoral Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Dec 17, 2008 as substantially equivalent to K052787 (Exactech, Inc., 2005) after a 30-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 17, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961304 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK961304 Aura Hip System Cemented Femoral Stem/Cemented Long Femoral StemExactech, Inc. · 1996
- 2 generations backK001335 Acumatch L-Series Cemented Femoral Stem, Model L-Series CementedExactech, Inc. · 2000
- 1 generation backK052787 Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch…Exactech, Inc. · 2005
- This deviceK083392 Novation 12/14 Cemented Femoral StemsExactech, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK090764 Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961304 | Aura Hip System Cemented Femoral Stem/Cemented Long Femoral Stem | Exactech, Inc. | 1996 | — |
| −2 | K001335 | Acumatch L-Series Cemented Femoral Stem, Model L-Series Cemented | Exactech, Inc. | 2000 | — |
| −1 | K052787 | Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14… | Exactech, Inc. | 2005 | — |
| 0 (this device) | K083392 | Novation 12/14 Cemented Femoral Stems | Exactech, Inc. | 2008 | — |
| +1 | K090764 | Novation CFS Press-Fit and Cemented Stems | Exactech, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052787 | Acumatch 12/14 C-Series Cemented Femoral Stems (Size 1-6), Acumatch 12/14 L-Series…Summary page 1…us, uncemented Information on devices to which Substantial equivalence is claimed: 510(k) Number Trade or Proprietary or Model Name Manufacturer K052787 Novation® 12/14 Cemented Femoral Stems Exactech, Inc.… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090764 | Novation CFS Press-Fit and Cemented Stems | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2016 | Class II | Z-1030-2017 | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090764 (Exactech, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 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 (138 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.
https://510kreport.com/device/K083392 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083392: Novation 12/14 Cemented Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083392
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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