510(k) · Cleared
ClearedExtremity Medical Midfoot 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 Apr 23, 2009 as substantially equivalent to K050683 (Synthes (Usa), 2005) and 3 other predicates after a 204-day review. Its family tree reaches back 4 generations to 1996. 63 later devices descend from it.
- Decided
- Apr 23, 2009
- Review
- 204 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962823 (1996). 14 ancestors in all, the oldest K792022 (1979). 63 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 3 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 2 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 1 generation backK081934 Extremity Medical Compression ScrewExtremity Medical, LLC · 2008
- This deviceK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
- Descendant · cites it directly · 56 of its ownK101700 IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · Recalled
- Descendant · cites it directly · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
- Descendant · 2 generations on · 22 of its ownK142581 APTUS Foot SystemMedartis AG · 2015
- Descendant · 2 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · 3 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · cites it directly56descendants
- K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017 · cites it directly24descendants
- K142581APTUS Foot SystemMedartis AG · 2015 · 2 generations on22descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 2 generations on21descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −3 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −2 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −1 | K081934 | Extremity Medical Compression Screw | Extremity Medical, LLC | 2008 | — |
| 0 (this device) | K082934 | Extremity Medical Midfoot Screw System | Extremity Medical, LLC | 2009 | — |
| +1 | K101700 | IO Fix Hand, IO Fix Foot, Extremity Medical Screw System | Extremity Medical, LLC | 2010 | 2 |
| +1 | K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | Extremity Medical, LLC | 2017 | — |
| +2 | K142581 | APTUS Foot System | Medartis AG | 2015 | — |
| +2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +3 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 11 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K050683 | Synthes (Usa) 3.5MM Conical ScrewsSummary page 1…fixation fastener Number 21 CFR 888.3040 Product Code HWC Predicate Devices 1. 3.5 Fully Threaded Screw, Synthes K050683 2. EXTREMITY MEDICAL Compression Screw K081934 3. Pioneer Medical,… | 2005 |
| * | K081934 | Extremity Medical Compression ScrewSummary page 1…Code HWC Predicate Devices 1. 3.5 Fully Threaded Screw, Synthes K050683 2. EXTREMITY MEDICAL Compression Screw K081934 3. Pioneer Medical, Stayfuse K022726 4. 6.5 Midfoot Fusion Bolt,… | 2008 |
| * | K022726 | Stayfuse GT-IPSummary page 1…Threaded Screw, Synthes K050683 2. EXTREMITY MEDICAL Compression Screw K081934 3. Pioneer Medical, Stayfuse K022726 4. 6.5 Midfoot Fusion Bolt, Synthes K081071 Device Description The EXTREMITY MEDICAL Mi… | 2002 |
| * | K081071 | Synthes 6.5MM Midfoot Fusion BoltSummary page 1…EDICAL Compression Screw K081934 3. Pioneer Medical, Stayfuse K022726 4. 6.5 Midfoot Fusion Bolt, Synthes K081071 Device Description The EXTREMITY MEDICAL Micdfoot Screw System Indications fo~r use The Extremity Medical Midfoot… | 2008 |
What descends from it? (63)
See all 635 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101700 | IO Fix Hand, IO Fix Foot, Extremity Medical Screw System | 2010 | 56 |
| K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | 2017 | 24 |
| K091577 | Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw System | 2009 | 4 |
| K093770 | Extremity Medical Screw System | 2010 | 3 |
| K121417 | XMCP, Hallux, Tarsx, Extremity Medical Screw System | 2012 | 2 |
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 3.3 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K101700 (Extremity Medical, LLC, 2010) has gone furthest, with 56 descendants of its own.
- 2 other devices also cite its predicate K050683.
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, and calcaneocuboid joints.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082934: Extremity Medical Midfoot Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082934
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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