510(k) · Cleared
ClearedLeforte System Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeil Medical Corporation · HWC Screw, Fixation, Bone
Cleared on Apr 18, 2003 as substantially equivalent to K971069 (Landos, Inc., 1997) and 2 other predicates after a 193-day review. Its family tree reaches back 2 generations to 1979. 20 later devices descend from it.
- Decided
- Apr 18, 2003
- Review
- 193 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792022 (1979). 12 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK960533 K3 Bone Screw SystemKinetikos Medical, Inc. · 1996
- This deviceK023365 Leforte System Bone ScrewJeil Medical Corporation · 2003
- Descendant · cites it directly · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
- Descendant · cites it directly · 8 of its ownK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- Descendant · 2 generations on · 5 of its ownK161864 ARIX Foot SystemJeil Medical Corporation · 2016
- Descendant · 3 generations on · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
- Descendant · 2 generations on · 4 of its ownK170780 ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K131311Arix Foot SystemJeil Medical Corporation · 2013 · cites it directly9descendants
- K050669Jeil Bone Fixation SystemJeil Medical Corporation · 2005 · cites it directly8descendants
- K161864ARIX Foot SystemJeil Medical Corporation · 2016 · 2 generations on5descendants
- K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · 3 generations on4descendants
- K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K960533 | K3 Bone Screw System | Kinetikos Medical, Inc. | 1996 | — |
| 0 (this device) | K023365 | Leforte System Bone Screw | Jeil Medical Corporation | 2003 | — |
| +1 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
| +1 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| +2 | K161864 | ARIX Foot System | Jeil Medical Corporation | 2016 | — |
| +3 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
| +2 | K170780 | ARIX Foot System (2.3/2.8) | Jeil Medical Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K971069 | Twist-Off (TM) ScrewSummary page 1…ew Classification Name: Screw, Fixation, Bone, Product Code HWC: CornmodUsual Name: Bone Screw 2. Equivalent legally marketed device: Twist ofFMScrew Medinov-AMP, K97 1069, Aesculap Titanium Alloy Bone Screws Aesculp, Inc., K970549, K3 Bone Screw System, Kinetikos Medical Inc., K960533 3. Indi… | 1997 |
| * | K970549 | Titanium Alloy Bone ScrewsSummary page 1…WC: CornmodUsual Name: Bone Screw 2. Equivalent legally marketed device: Twist ofFMScrew Medinov-AMP, K97 1069, Aesculap Titanium Alloy Bone Screws Aesculp, Inc., K970549, K3 Bone Screw System, Kinetikos Medical Inc., K960533 3. Indications for Use (intended use) . The Leforte System Screws are… | 1997 |
| * | K960533 | K3 Bone Screw SystemSummary page 1…y marketed device: Twist ofFMScrew Medinov-AMP, K97 1069, Aesculap Titanium Alloy Bone Screws Aesculp, Inc., K970549, K3 Bone Screw System, Kinetikos Medical Inc., K960533 3. Indications for Use (intended use) . The Leforte System Screws are intended for fracture fixation as well as reconstructio… | 1996 |
What descends from it? (20)
See all 203 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 24 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K131311 (Jeil Medical Corporation, 2013) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K971069.
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 Leforte System Screws are intended for fracture fixation as well as reconstruction and stabilization of small bones (i.e. toe, foot, finger, hand, etc) and the mandibulofacial (i.e. mandible and maxilla) bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023365: Leforte System Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023365
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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