510(k) · Cleared
ClearedBti Cortical Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodynamic Technologies, Inc. · HWC Screw, Fixation, Bone
Cleared on Aug 29, 1997 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Aug 29, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK972403 Bti Cortical Bone ScrewsBiodynamic Technologies, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
- Descendant · cites it directly · 3 of its ownK071035 Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK130613 Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014
- Descendant · 3 generations on · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK140216 Orthopedic Fixation SystemsImpact Medical, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007 · cites it directly4descendants
- K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007 · cites it directly3descendants
- K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014 · 2 generations on1descendant
- K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · 3 generations on0descendants
- K140216Orthopedic Fixation SystemsImpact Medical, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972403 | Bti Cortical Bone Screws | Biodynamic Technologies, Inc. | 1997 | — |
| +1 | K063589 | Gso Bone Fixation Fasteners | Gold Standard Orthopaedics, LLC | 2007 | — |
| +1 | K071035 | Ifs Bone Fixation Devices | Internal Fixation Systems, Inc. | 2007 | — |
| +2 | K130613 | Cannulated Screw and Kirschner (Kwire) System | Laura Cattabriga | 2014 | — |
| +3 | K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025 | — |
| +2 | K140216 | Orthopedic Fixation Systems | Impact Medical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2014 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 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?
- Of its descendants, K063589 (Gold Standard Orthopaedics, LLC, 2007) has gone furthest, with 4 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.
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 BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malieolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTl Compression Hip Screw System, BT! Humeral Intramedullary Rod Systems, and the BTl Distal Femoral Intramedullary Rod System.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972403: Bti Cortical Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972403
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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