510(k) · Cleared
ClearedExtremity Medical Calcaneal Osteotomy Device
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 Mar 4, 2015 as substantially equivalent to K143402 (Extremity Medical, LLC, 2015) after a 23-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Mar 4, 2015
- Review
- 23 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962823 (1996). 37 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK081934 Extremity Medical Compression ScrewExtremity Medical, LLC · 2008
- 4 generations backK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
- 3 generations backK101700 IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · Recalled
- 2 generations backK121349 IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC · 2012
- 1 generation backK143402 Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC · 2015
- This deviceK150309 Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K081934 | Extremity Medical Compression Screw | Extremity Medical, LLC | 2008 | — |
| −4 | K082934 | Extremity Medical Midfoot Screw System | Extremity Medical, LLC | 2009 | — |
| −3 | K101700 | IO Fix Hand, IO Fix Foot, Extremity Medical Screw System | Extremity Medical, LLC | 2010 | 2 |
| −2 | K121349 | IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and Washer | Extremity Medical, LLC | 2012 | — |
| −1 | K143402 | Extremity Medical Calcaneal Osteotomy Device | Extremity Medical, LLC | 2015 | — |
| 0 (this device) | K150309 | Extremity Medical Calcaneal Osteotomy Device | Extremity Medical, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K143402 | Extremity Medical Calcaneal Osteotomy DeviceSummary page 4…nd Number 21 CFR 888.3040 Product Code HWC (screw, fixation, bone), HRS (plate, fixation, bone) Predicate Devices K143402 – Calcaneal Osteotomy Device (Extremity Medical) Device Description The Calcaneal Osteotomy Device is a bone fixation d… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 12 of the 37 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150309: Extremity Medical Calcaneal Osteotomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150309
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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