510(k) · Cleared
ClearedAlteon 6.5MM Bone Screws
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 Jul 29, 2014 as substantially equivalent to K993082 (Exactech, Inc., 1999) after a 27-day review. Its family tree reaches back 2 generations to 1993. 6 later devices descend from it.
- Decided
- Jul 29, 2014
- Review
- 27 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921114 (1993). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK921114 Exactech MCS Porous Coated Total Hip AcetabularExactech, Inc. · 1993
- 1 generation backK993082 Exactech Acumatch Integrated Hip System a-Series Porous Coated…Exactech, Inc. · 1999 · Recalled
- This deviceK141797 Alteon 6.5MM Bone ScrewsExactech, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK182346 TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK241597 Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK251717 Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK252777 Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253314 Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc. · 2018 · cites it directly5descendants
- K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · 2 generations on3descendants
- K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc. · 2025 · 3 generations on1descendant
- K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc. · 2025 · 3 generations on0descendants
- K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921114 | Exactech MCS Porous Coated Total Hip Acetabular | Exactech, Inc. | 1993 | — |
| −1 | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular… | Exactech, Inc. | 1999 | 2 |
| 0 (this device) | K141797 | Alteon 6.5MM Bone Screws | Exactech, Inc. | 2014 | — |
| +1 | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | Exactech, Inc. | 2018 | — |
| +2 | K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +3 | K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025 | — |
| +3 | K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025 | — |
| +3 | K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 LPH? 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? (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 |
|---|---|---|---|
| * | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentSummary page 1…Which Substantial Equivalence Is Claimed: Name Manufacturer 510(k) Number Exactech 6.5mm Cancellous Bone Screws Exactech, Inc K993082E Indication for Use: All Exactech Hip Systems are indicated for use in skeletally mature individuals un dergoing primary surgery… | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | 2018 | 5 |
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 21 years and passes through 1 company; a new generation was cleared every 14.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K182346 (Exactech, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K993082.
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. 2014, 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 arc also potentially indicated for ankylosing…
Read the full statement (123 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 arc 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.
* Femnoral 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/K141797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141797: Alteon 6.5MM Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141797
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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