510(k) · Cleared
ClearedAdditive Orthopaedics Bunion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Orthopaedics, LLC · HRS Plate, Fixation, Bone
Cleared on Jun 20, 2017 as substantially equivalent to K131061 (Nextremity Solutions, 2013) and 3 other predicates after a 181-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Jun 20, 2017
- Review
- 181 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K954385 (1996). 156 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 2 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 1 generation backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- This deviceK163593 Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC · 2017
Show all 11 generations
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 9 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 8 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 7 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 6 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 5 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 4 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 3 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 2 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 1 generation backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- This deviceK163593 Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −10 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −9 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −8 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −7 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −6 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −5 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −4 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −3 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −2 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −1 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| 0 (this device) | K163593 | Additive Orthopaedics Bunion System | Additive Orthopaedics, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 14 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 11 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 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.
Planning a device in HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K131061 | Restore Bunion Correction SystemSummary page 4…Primary: Nextremity Solutions, Inc. Restore Fixation System K131061 Additional: OrthoHelix Surgical Designs, Inc. Mini MaxLock Extreme Plating System… | 2013 |
| * | K120157 | Mini Maxlock Extreme Plating SystemSummary page 4…Additional: OrthoHelix Surgical Designs, Inc. Mini MaxLock Extreme Plating System K120157 Additional: Osteomed ExtremiLock System… | 2012 |
| * | K131445 | Osteomed Extremilock Foot Plating SystemSummary page 4…Additional: Osteomed ExtremiLock System K131445 Additional: OrthoSolutions, Inc. Ultos Foot Plating system… | 2013 |
| * | K141784 | Ortho Solutions Ultos Plating SystemSummary page 4…Additional: OrthoSolutions, Inc. Ultos Foot Plating system K141784 Reference: Additive Orthopaedics, LLC Hammertoe Correction System… | 2014 |
| † | K153207 | Additive Orthopaedics Bone Wedge System | 2016 |
| † | K160264 | Additive Orthopaedics Hammertoe Correction System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 1.0 years on median.
- 27 of the 156 ancestors have a recall of any class.
- 3 other devices also cite its predicate K131061.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163593 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163593: Additive Orthopaedics Bunion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163593
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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