510(k) · Cleared
ClearedExtremity Medical Midfoot Screw System, Charcx, Intramedullary Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Extremity Medical, LLC · HWC Screw, Fixation, Bone
Cleared on Jul 24, 2009 as substantially equivalent to K082934 (Extremity Medical, LLC, 2009) and 1 other predicate after a 52-day review. Its family tree reaches back 5 generations to 1996. 4 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 52 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962823 (1996). 15 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 4 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 3 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 2 generations backK081934 Extremity Medical Compression ScrewExtremity Medical, LLC · 2008
- 1 generation backK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
- This deviceK091577 Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw…Extremity Medical, LLC · 2009
- Descendant · cites it directly · 3 of its ownK093770 Extremity Medical Screw SystemExtremity Medical, LLC · 2010
- Descendant · cites it directly · 2 of its ownK121417 XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK200124 InCore MPJ SystemNextremity Solutions, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK130120 Extremity Medical IP Fusion SystemExtremity Medical, LLC · 2013
Most influential descendants
Showing 4 of 4 · See all- K093770Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · cites it directly3descendants
- K121417XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC · 2012 · cites it directly2descendants
- K200124InCore MPJ SystemNextremity Solutions, Inc. · 2020 · 2 generations on0descendants
- K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −4 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −3 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −2 | K081934 | Extremity Medical Compression Screw | Extremity Medical, LLC | 2008 | — |
| −1 | K082934 | Extremity Medical Midfoot Screw System | Extremity Medical, LLC | 2009 | — |
| 0 (this device) | K091577 | Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw System | Extremity Medical, LLC | 2009 | — |
| +1 | K093770 | Extremity Medical Screw System | Extremity Medical, LLC | 2010 | — |
| +1 | K121417 | XMCP, Hallux, Tarsx, Extremity Medical Screw System | Extremity Medical, LLC | 2012 | — |
| +2 | K200124 | InCore MPJ System | Nextremity Solutions, Inc. | 2020 | — |
| +2 | K130120 | Extremity Medical IP Fusion System | Extremity Medical, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K082934 | Extremity Medical Midfoot Screw SystemSummary page 1…xation fastener and Number 21 CFR 888.3040 Product Code HWC Predicate Devices 1. EXTREMITY MEDICAL Midfoot Screw System K082934 2. 3.5 Fully Threaded Screw, Synthes K050683 Device Description The EXTREMITY MEDICAL… | 2009 |
| * | K050683 | Synthes (Usa) 3.5MM Conical ScrewsSummary page 1…HWC Predicate Devices 1. EXTREMITY MEDICAL Midfoot Screw System K082934 2. 3.5 Fully Threaded Screw, Synthes K050683 Device Description The EXTREMITY MEDICAL Midfoot Screw System Indications for use The Extremity Medical Midfoo… | 2005 |
What descends from it? (4)
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K093770 (Extremity Medical, LLC, 2010) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K082934.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091577: Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091577
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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