510(k) · Cleared
ClearedInCore® Lapidus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nextremity Solutions, Inc. · HWC Screw, Fixation, Bone
Cleared on Apr 25, 2018 as substantially equivalent to K121349 (Extremity Medical, LLC, 2012) and 1 other predicate after an 85-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it.
- Decided
- Apr 25, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962823 (1996). 38 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 5 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 4 generations backK081934 Extremity Medical Compression ScrewExtremity Medical, LLC · 2008
- 3 generations backK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
- 2 generations backK101700 IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · Recalled
- 1 generation backK121349 IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC · 2012
- This deviceK180257 InCore® Lapidus SystemNextremity Solutions, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK192578 InCore TMT SystemNextremity Solutions, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK200124 InCore MPJ SystemNextremity Solutions, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK190231 InCore® Lapidus Sterile KitsNextremity Solutions, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −6 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −5 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −4 | K081934 | Extremity Medical Compression Screw | Extremity Medical, LLC | 2008 | — |
| −3 | K082934 | Extremity Medical Midfoot Screw System | Extremity Medical, LLC | 2009 | — |
| −2 | K101700 | IO Fix Hand, IO Fix Foot, Extremity Medical Screw System | Extremity Medical, LLC | 2010 | 2 |
| −1 | K121349 | IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer | Extremity Medical, LLC | 2012 | — |
| 0 (this device) | K180257 | InCore® Lapidus System | Nextremity Solutions, Inc. | 2018 | — |
| +1 | K192578 | InCore TMT System | Nextremity Solutions, Inc. | 2019 | — |
| +1 | K200124 | InCore MPJ System | Nextremity Solutions, Inc. | 2020 | — |
| +1 | K190231 | InCore® Lapidus Sterile Kits | Nextremity Solutions, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K121349 | IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherSummary page 4…astener; Class II Product Code: HWC Substantially Equivalent Devices: Extremity Medical Screw and Washer System (IO FiX), K121349 – Primary Predicate Phalanx Innovations OsteoBullet Compression Screw, K… | 2012 |
| * | K160304 | OsteoBullet Compression ScrewSummary page 4…Screw and Washer System (IO FiX), K121349 – Primary Predicate Phalanx Innovations OsteoBullet Compression Screw, K160304 Nextremity Solutions Axi+Line Proximal Bunion Correction System, K152548… | 2016 |
| † | K152548 | AXI+LINE Proximal Bunion Correction System | 2015 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 38 ancestors have a recall of any class.
- Of its descendants, K192578 (Nextremity Solutions, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K121349.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Nextremity Solutions InCore® Lapidus System is a three-part construct intended for internal fixation for
First Metatarsocuneiform arthrodesis (also known as Lapidus or First Tarsometatarsal Fusion).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180257 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180257: InCore® Lapidus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180257
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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