510(k) · Cleared
Recalled · Class II · 2016Novation Splined RDD 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 Nov 29, 2006 as substantially equivalent to K042842 (Exactech, Inc., 2004) after a 29-day review. Its family tree reaches back 6 generations to 1994. It has been recalled 2 times.
- Decided
- Nov 29, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931641 (1994). 18 ancestors in all, the oldest K862234 (1986). No later device cites it as a predicate yet.
- 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 deviceK063279 Novation Splined RDD Femoral StemsExactech, Inc. · 2006
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) | K063279 | Novation Splined RDD Femoral Stems | Exactech, Inc. | 2006 | — |
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 |
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 2…Information on devices to which substantial equivalence is claimed: 510(k) Trade or Proprietary or Model Name Manufacturer Number #K042842 Novation 12/14 Press-Fit Femoral Stems Exactech, Inc. INDICATIONS FOR USE: All Exactech Hip Syst… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 26, 2016 | Class II | Z-2127-2016 | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. |
| May 26, 2016 | Class II | Z-2128-2016 | Under Investigation by firm | Labeled with the incorrect Global Trade Item Number (GTIN). 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 3 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 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.
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 (139 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/K063279 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063279: Novation Splined RDD 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/K063279
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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