510(k) · Cleared
ClearedHammerTechTM 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 Nov 23, 2018 as substantially equivalent to K161449 (Fusion Orthopedics, LLC, 2016) and 2 other predicates after a 58-day review. Its family tree reaches back 8 generations to 2002.
- Decided
- Nov 23, 2018
- Review
- 58 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K013888 (2002). 48 ancestors in all, the oldest K792670 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 7 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 6 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- 5 generations backK111536 Metasurg Digifuse ImplantMetasurg · 2011
- 4 generations backK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- 3 generations backK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- 2 generations backK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- 1 generation backK150252 PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015
- This deviceK182684 HammerTechTM Fixation SystemFusion Orthopedics, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −7 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −6 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| −5 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| −4 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| −3 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| −2 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| −1 | K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015 | — |
| 0 (this device) | K182684 | HammerTechTM Fixation System | Fusion Orthopedics, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K161449 | HammerTech Fixation SystemSummary page 4…CFR Section 21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate HammerTechTM Fixation System, Fusion Orthopedics (K161449) Device PHALINX Hammertoe System, Wright Medical Technology, Incorporated (K150252) K- Secondary… | 2016 |
| * | K150252 | PHALINX Hammertoe SystemSummary page 4…HammerTechTM Fixation System, Fusion Orthopedics (K161449) Device PHALINX Hammertoe System, Wright Medical Technology, Incorporated (K150252) K- Secondary Wire, Trilliant Surgical (K121008) Predicate Device The HammerTech Fixatio… | 2015 |
| * | K121008 | Trilliant Surgical K-WiresSummary page 4…61449) Device PHALINX Hammertoe System, Wright Medical Technology, Incorporated (K150252) K- Secondary Wire, Trilliant Surgical (K121008) Predicate Device The HammerTech Fixation System consists of PEEK (Polyetheretherketone (ASTM… | 2012 |
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 16 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 48 ancestors have a recall of any class.
- 1 other device also cites its predicate K161449.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 as stated in the FDA summary.
https://510kreport.com/device/K182684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182684: HammerTechTM 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/K182684
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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