510(k) · Cleared
ClearedOsteomed Extremifuse System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · HWC Screw, Fixation, Bone
Cleared on May 31, 2013 as substantially equivalent to K101165 (Wrightmedicaltechnologyinc, 2010) and 2 other predicates after a 101-day review. Its family tree reaches back 3 generations to 2002. 4 later devices descend from it.
- Decided
- May 31, 2013
- Review
- 101 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K013888 (2002). 11 ancestors in all, the oldest K954330 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 2 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 1 generation backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- This deviceK130412 Osteomed Extremifuse SystemOsteomed · 2013
- Descendant · cites it directly · 2 of its ownK133515 Peek Fusion ImplantMtp Solutions, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK211996 Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK140970 One-Piece Peek Fusion ImplantMtp Solutions, LLC · 2014
- Descendant · cites it directly · 0 of its ownK140283 Osteomed Extremifuse SystemOsteomed · 2014
Most influential descendants
Showing 4 of 4 · See all- K133515Peek Fusion ImplantMtp Solutions, LLC · 2014 · cites it directly2descendants
- K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc. · 2021 · 2 generations on0descendants
- K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC · 2014 · 2 generations on0descendants
- K140283Osteomed Extremifuse SystemOsteomed · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −2 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −1 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| 0 (this device) | K130412 | Osteomed Extremifuse System | Osteomed | 2013 | — |
| +1 | K133515 | Peek Fusion Implant | Mtp Solutions, LLC | 2014 | — |
| +2 | K211996 | Nexta PEEK Hammertoe Correction System | Nextremity Solutions, Inc. | 2021 | — |
| +2 | K140970 | One-Piece Peek Fusion Implant | Mtp Solutions, LLC | 2014 | — |
| +1 | K140283 | Osteomed Extremifuse System | Osteomed | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K101165 | Pro-Toe VO Hammertow Implant SystemSummary page 1…o HWC Device Class: 11 Predicate Devices: Pro-Toe VO HammerToe Implant System. K1 01165 Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR… | 2010 |
| * | K091614 | Osteomed Foot Plating SystemSummary page 3…nt System (K101165), and similarities in material, function, and performance to the OsteoMed Cannulated Screw System (K062863) and OsteoMed Foot Plating System, K-Wires (K091614). Substantial equivalence was shown through the pullout test, torque test, and bending test to the predicate devices. The indica… | 2009 |
| * | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw SystemSummary page 1…888.3040, Product Code HWC) Device Class: 11I OsteoMed Extended 2.0/2.4 Cannulated Screw System. K062863 Classification Name: Smooth or threaded metallic bone fixation fastener (21IFIR… | 2006 |
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 11 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K133515 (Mtp Solutions, LLC, 2014) has gone furthest, with 2 descendants of its own.
- 13 other devices also cite its predicate K101165.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130412: Osteomed Extremifuse System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130412
Report an extraction error
Are you the manufacturer?
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