510(k) · Cleared
ClearedLapidus Screw Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Relja Innovations, LLC · HWC Screw, Fixation, Bone
Cleared on Jul 22, 2026 as substantially equivalent to K211628 (Relja Innovations, LLC, 2022) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Jul 22, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K792022 (1979). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 3 generations backK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- 2 generations backK070039 Memometal Fixos ScrewsMemometal Technologies · 2007
- 1 generation backK211628 MIS Precision Chevron Bunion SystemRelja Innovations, LLC · 2022
- This deviceK262075 Lapidus Screw KitRelja Innovations, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −3 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| −2 | K070039 | Memometal Fixos Screws | Memometal Technologies | 2007 | — |
| −1 | K211628 | MIS Precision Chevron Bunion System | Relja Innovations, LLC | 2022 | — |
| 0 (this device) | K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K211628 | MIS Precision Chevron Bunion SystemSummary page 6…pidus Screw Kit is substantially equivalent to the following legally marketed predicate devices: Primary Predicate: Relja – MIS Precision Chevron Bunion System – K211628 Additional Predicates: Stryker Trauma AG – Fixos Screw System – K133451 The subject Lapidus Screw Kits are identical in e… | 2022 |
| * | K133451 | Fixos Screw SystemSummary page 6…redicate devices: Primary Predicate: Relja – MIS Precision Chevron Bunion System – K211628 Additional Predicates: Stryker Trauma AG – Fixos Screw System – K133451 The subject Lapidus Screw Kits are identical in every way to the primary predicate device, except the subject screws are offered… | 2014 |
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 47 years and passes through 4 companies; a new generation was cleared every 14.9 years on median.
- 2 of the 14 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Lapidus Screw Kit is intended for use in first tarsometatarsal (Lapidus) arthrodesis and elective osteotomies involving the midfoot, metatarsals, and phalanges of the foot.
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/K262075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262075: Lapidus Screw Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262075
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026