510(k) · Cleared
ClearedHammerTech Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusion Orthopedics, LLC · HWC Screw, Fixation, Bone
Cleared on Oct 11, 2016 as substantially equivalent to K133636 (Extremity Medical, LLC, 2014) and 1 other predicate after a 139-day review. Its family tree reaches back 5 generations to 1990. 5 later devices descend from it.
- Decided
- Oct 11, 2016
- Review
- 139 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K901456 (1990). 30 ancestors in all, the oldest K792670 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 4 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 3 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- 2 generations backK061164 ActivapinBioretec, Ltd. · 2006
- 1 generation backK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- This deviceK161449 HammerTech Fixation SystemFusion Orthopedics, LLC · 2016
- Descendant · cites it directly · 3 of its ownK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK213421 Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK250613 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK182684 HammerTechTM Fixation SystemFusion Orthopedics, LLC · 2018
Most influential descendants
Showing 5 of 5 · See all- K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly3descendants
- K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021 · 2 generations on2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 3 generations on1descendant
- K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025 · 4 generations on0descendants
- K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −4 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −3 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| −2 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| −1 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| 0 (this device) | K161449 | HammerTech Fixation System | Fusion Orthopedics, LLC | 2016 | — |
| +1 | K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +3 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
| +4 | K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025 | — |
| +1 | K182684 | HammerTechTM Fixation System | Fusion Orthopedics, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K133636 | Extremity Medical Hammertoe DeviceSummary page 4…Code HWC CFR Section 21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate HammerFiX, Extremity Medical, LLC (K133636) Device Secondary Predicate K-wire, Trilliant Surgical (K121008) Device The HammerTech® Fixation… | 2014 |
| * | K121008 | Trilliant Surgical K-WiresSummary page 4…40 Device Panel Orthopedic Primary Predicate HammerFiX, Extremity Medical, LLC (K133636) Device Secondary Predicate K-wire, Trilliant Surgical (K121008) Device The HammerTech® Fixation System implant is a polyetheretherketone (P… | 2012 |
What descends from it? (5)
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 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 30 ancestors have a recall of any class.
- Of its descendants, K201850 (Nvision Biomedical Technologies, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K133636.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 HammerTech® device 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161449: HammerTech Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161449
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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