510(k) · Cleared
Recalled · Class II · 2016Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving Femoral Stem, Extended Offset
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 Aug 28, 2014 as substantially equivalent to K121684 (Exactech, Inc., 2012) after a 52-day review. Its family tree reaches back 10 generations to 1996. 1 of the 92 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Aug 28, 2014
- Review
- 52 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K955033 (1996). 92 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet. 1 of the 92 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 6 generations between
- 3 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 2 generations backK112682 Metha Hip SystemAesculap Implant Systems, LLC · 2012
- 1 generation backK121684 Novation Lpi Prime Femoral StemExactech, Inc. · 2012
- This deviceK141821 Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7…Exactech, Inc. · 2014
Show all 10 generations
- Root · 10 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 9 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 8 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 7 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 6 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 5 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 4 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 3 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 2 generations backK112682 Metha Hip SystemAesculap Implant Systems, LLC · 2012
- 1 generation backK121684 Novation Lpi Prime Femoral StemExactech, Inc. · 2012
- This deviceK141821 Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7…Exactech, Inc. · 2014
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks3 generations back · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −9 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −8 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −7 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −6 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −5 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −4 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −3 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| −2 | K112682 | Metha Hip System | Aesculap Implant Systems, LLC | 2012 | — |
| −1 | K121684 | Novation Lpi Prime Femoral Stem | Exactech, Inc. | 2012 | — |
| 0 (this device) | K141821 | Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck… | Exactech, Inc. | 2014 | — |
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 |
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 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 |
|---|---|---|---|
| * | K121684 | Novation Lpi Prime Femoral StemSummary page 4…ubstantial Equivalence Is Claimed: Name Manufacturer 510(k) Number Exactech Novation LPI Prime Femoral Exactech, Inc K121684 Stem Indication for Use: All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary sur… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2016 | Class II | Z-1032-2017 | Under Investigation by firm | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. |
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 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 25 of the 91 ancestors have a recall of any class; 1 has a Class I recall.
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. 2014, 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 (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/K141821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141821: Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving Femoral Stem, Extended Offset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141821
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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