510(k) · Cleared
ClearedNovation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20
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 Nov 8, 2010 as substantially equivalent to K042842 (Exactech, Inc., 2004) after a 70-day review. Its family tree reaches back 6 generations to 1994. 54 later devices descend from it.
- Decided
- Nov 8, 2010
- Review
- 70 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931641 (1994). 18 ancestors in all, the oldest K862234 (1986). 54 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 4 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 3 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 2 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 1 generation backK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004
- This deviceK102487 Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset…Exactech, Inc. · 2010
- Descendant · cites it directly · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
- Descendant · 2 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
- Descendant · 3 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
- Descendant · 4 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · 2 generations on · 17 of its ownK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- 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
- K162719iTotal® Hip Replacement SystemConformis, Inc. · 2017 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −5 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −4 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −3 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −2 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −1 | K042842 | Novation 12/14 Press-Fit Femoral Stem | Exactech, Inc. | 2004 | — |
| 0 (this device) | K102487 | Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma… | Exactech, Inc. | 2010 | — |
| +1 | K112802 | Pipeline Total Hip System | Pipeline Orthopedics | 2012 | — |
| +2 | K122158 | PBP Total Hip System | Pipeline Biomedical Products, LLC | 2012 | — |
| +3 | K131237 | Pipeline Total Hip System | Pipeline Orthopedics | 2013 | — |
| +4 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +2 | K162719 | iTotal® Hip Replacement System | Conformis, Inc. | 2017 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K042842 | Novation 12/14 Press-Fit Femoral StemSummary page 1…Code mDI) 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 Indications for Use: All Exactech Hip Systems are in… | 2004 |
What descends from it? (54)
See all 541 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112802 | Pipeline Total Hip System | 2012 | 53 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K112802 (Pipeline Orthopedics, 2012) has gone furthest, with 53 descendants of its own.
- 5 other devices also cite its predicate K042842.
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. 2010, 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 (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.
https://510kreport.com/device/K102487 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102487: Novation Femoral Stem, Tapered 12/14 , Standard/Extended Offset, Plasma Coated, Press-Fit, Size 19/20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102487
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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