510(k) · Cleared
ClearedNovation Lpi Prime Femoral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Oct 1, 2012 as substantially equivalent to K080584 (Aesculap Implant System, Inc., 2008) and 1 other predicate after a 116-day review. Its family tree reaches back 9 generations to 1996. 1 of the 92 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 1, 2012
- Review
- 116 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K955033 (1996). 91 ancestors in all, the oldest K840643 (1984). 1 later device descends from it, 1 citing it directly. 1 of the 92 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 5 generations between
- 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 1 generation backK112682 Metha Hip SystemAesculap Implant Systems, LLC · 2012
- This deviceK121684 Novation Lpi Prime Femoral StemExactech, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK141821 Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7…Exactech, Inc. · 2014 · Recalled
Show all 9 generations
- Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 8 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 7 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 6 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 5 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 4 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 1 generation backK112682 Metha Hip SystemAesculap Implant Systems, LLC · 2012
- This deviceK121684 Novation Lpi Prime Femoral StemExactech, Inc. · 2012
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks2 generations back · 2009
Most influential descendants
Showing 1 of 1 · See all- K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −8 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −7 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −6 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −5 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −4 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| −1 | K112682 | Metha Hip System | Aesculap Implant Systems, LLC | 2012 | — |
| 0 (this device) | K121684 | Novation Lpi Prime Femoral Stem | Exactech, Inc. | 2012 | — |
| +1 | K141821 | Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck… | Exactech, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
1 device in this family has a Class I recall. 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080584 | Metha Short Stem Hip SystemSummary page 1…Which Substantial Equivalence Is Claimed: Name Manufacturer 510(k) Number Metha Short Stem Hip System Aesculap K080584 and Ki112682 Device Description The Ndvation LPI Prime Femoral Stem is a titanium press-fit prosthesis featuring a 12/14 trunnio… | 2008 |
| * | K112682 | Metha Hip SystemSummary page 1…ial Equivalence Is Claimed: Name Manufacturer 510(k) Number Metha Short Stem Hip System Aesculap K080584 and Ki112682 Device Description The Ndvation LPI Prime Femoral Stem is a titanium press-fit prosthesis featuring a 12/14 trunnion that is use… | 2012 |
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 |
|---|---|---|---|
| K141821 | Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving… | 2014 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 25 of the 90 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K141821 (Exactech, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K080584.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
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 (120 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.
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/K121684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121684: Novation Lpi Prime 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/K121684
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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