510(k) · Cleared
ClearedIO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer
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 18, 2012 as substantially equivalent to K101700 (Extremity Medical, LLC, 2010) after a 75-day review. Its family tree reaches back 6 generations to 1996. 12 later devices descend from it.
- Decided
- Jul 18, 2012
- Review
- 75 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962823 (1996). 16 ancestors in all, the oldest K792022 (1979). 12 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK081934 Extremity Medical Compression ScrewExtremity Medical, LLC · 2008
- 2 generations backK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
- 1 generation backK101700 IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · Recalled
- This deviceK121349 IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC · 2012
- Descendant · cites it directly · 4 of its ownK172260 Omni Foot Plating SystemExtremity Medical, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK180808 Omni Foot Plating SystemExtremity Medical, LLC · 2018
- Descendant · cites it directly · 3 of its ownK180257 InCore® Lapidus SystemNextremity Solutions, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK212297 Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
- Descendant · cites it directly · 1 of its ownK192578 InCore TMT SystemNextremity Solutions, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K172260Omni Foot Plating SystemExtremity Medical, LLC · 2017 · cites it directly4descendants
- K180808Omni Foot Plating SystemExtremity Medical, LLC · 2018 · 2 generations on3descendants
- K180257InCore® Lapidus SystemNextremity Solutions, Inc. · 2018 · cites it directly3descendants
- K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021 · 3 generations on1descendant
- K192578InCore TMT SystemNextremity Solutions, Inc. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K081934 | Extremity Medical Compression Screw | Extremity Medical, LLC | 2008 | — |
| −2 | 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 |
| 0 (this device) | K121349 | IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer | Extremity Medical, LLC | 2012 | — |
| +1 | K172260 | Omni Foot Plating System | Extremity Medical, LLC | 2017 | — |
| +2 | K180808 | Omni Foot Plating System | Extremity Medical, LLC | 2018 | — |
| +1 | K180257 | InCore® Lapidus System | Nextremity Solutions, Inc. | 2018 | — |
| +3 | K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | 2021 | — |
| +1 | K192578 | InCore TMT System | Nextremity Solutions, Inc. | 2019 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K101700 | IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemSummary page 1…21 CFR 888.3040 Product Code H-WC Predicate Devices EXTREMITY MEDICAL Screw and Washer System, Extremity Medical (K101700) Reason for Submission Additional screw and washer options have been added to the system to allow for… | 2010 |
What descends from it? (12)
See all 125 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 16 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K172260 (Extremity Medical, LLC, 2017) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K101700.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, anile, hand, aiid wrist. The two-part construct is specifically intended for Talonavicular Calcaneocuboid, Metatarsocuneiform, Anle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121349: IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121349
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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