510(k) · Cleared
ClearedIntraLock Lapidus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusion Orthopedics, LLC · HWC Screw, Fixation, Bone
Cleared on May 21, 2019 after a 266-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- May 21, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
1 later device descends from it, 1 citing it directly.
- This deviceK182342 IntraLock Lapidus SystemFusion Orthopedics, LLC · 2019
- Descendant · cites it directly · 0 of its ownK210159 IntraLock SystemFusion Orthopedics, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K210159IntraLock SystemFusion Orthopedics, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182342 | IntraLock Lapidus System | Fusion Orthopedics, LLC | 2019 | — |
| +1 | K210159 | IntraLock System | Fusion Orthopedics, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K082636 | FDA’s K082636 is TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3T Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| Kept off the family tree | K090317 | FDA’s K090317 is Babi*Plus Bubble Pap Valve Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210159 | IntraLock System | 2021 | 0 |
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?
- Of its descendants, K210159 (Fusion Orthopedics, LLC, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, 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 · 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 IntraLock Lapidus System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints in the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182342: IntraLock Lapidus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182342
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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