510(k) · Cleared
ClearedAdditive Orthopaedics Patient Specific 3D Locking Lattice Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Orthopaedics · HRS Plate, Fixation, Bone
Cleared on Jan 10, 2019 as substantially equivalent to K170214 (Additive Orthopaedics, LLC, 2017) and 1 other predicate after a 71-day review. Its family tree reaches back 14 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 10, 2019
- Review
- 71 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K954385 (1996). 271 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 1 generation backK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
- This deviceK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
- Descendant · cites it directly · 4 of its ownK193614 FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK211646 FINE OsteotomyBodycad Laboratories, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK231314 Fine Osteotomy™Bodycad Laboratories, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK240066 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK240703 Fine Osteotomy™Bodycad Laboratories, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 12 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 11 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 10 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 9 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 8 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 7 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 6 generations backK102156 Maxlock Extreme Extremity Plating System Distal Radius Plates and…Orthohelix Surgical Designs, Inc. · 2010 · Recalled
- 5 generations backK111041 Mini Variable SystemOrthohelix Surgical Designs, Inc. · 2011
- 4 generations backK120157 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 3 generations backK121437 Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc. · 2012
- 2 generations backK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
- 1 generation backK170214 Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC · 2017
- This deviceK183011 Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics · 2019
Most influential descendants
Showing 5 of 5 · See all- K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc. · 2020 · cites it directly4descendants
- K211646FINE OsteotomyBodycad Laboratories, Inc. · 2021 · 2 generations on3descendants
- K231314Fine Osteotomy™Bodycad Laboratories, Inc. · 2023 · 3 generations on2descendants
- K240066Fine Osteotomy™Bodycad Laboratories, Inc. · 2024 · 4 generations on1descendant
- K240703Fine Osteotomy™Bodycad Laboratories, Inc. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −13 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −12 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −11 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −10 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −9 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −8 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −7 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −6 | K102156 | Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws | Orthohelix Surgical Designs, Inc. | 2010 | 1 |
| −5 | K111041 | Mini Variable System | Orthohelix Surgical Designs, Inc. | 2011 | — |
| −4 | K120157 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −3 | K121437 | Mini Maxlock Extreme Plating System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| −2 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
| −1 | K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | 2017 | — |
| 0 (this device) | K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | Additive Orthopaedics | 2019 | — |
| +1 | K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | 2020 | — |
| +2 | K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | 2021 | — |
| +3 | K231314 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2023 | — |
| +4 | K240066 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
| +5 | K240703 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 15 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 16 | 0 |
| 2001 | 19 | 0 |
| 2002 | 22 | 0 |
| 2003 | 9 | 0 |
| 2004 | 9 | 0 |
| 2005 | 19 | 0 |
| 2006 | 17 | 0 |
| 2007 | 12 | 0 |
| 2008 | 16 | 0 |
| 2009 | 16 | 0 |
| 2010 | 16 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K170214 | Additive Orthopaedics Locking Lattice PlateSummary page 4…Product Name 510K Number Additive Orthopaedics Locking Lattice Plates K170214 Additional Predicate Device: Company Product Name 510K Num… | 2017 |
| * | K162674 | BioPro Foot Plating SystemsSummary page 4…Product Name 510K Number BIOPRO, INC. BioPro Foot Plating System K162674 Reference Device: Company Product Name 510K Number Additi… | 2017 |
| † | K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | 2018 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193614 | FINE Osteotomy around the knee | 2020 | 4 |
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 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 55 of the 271 ancestors have a recall of any class.
- Of its descendants, K193614 (Bodycad Laboratories, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K170214.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Patient Specific 3D Printed Locking Lattice Plate is indicated for alignment, stabilization and
fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. It is a patient specific device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183011
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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