510(k) · Cleared
ClearedHammerlock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Ent., Inc. · HTY Pin, Fixation, Smooth
Cleared on Feb 19, 2010 after a 233-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 19, 2010
- Review
- 233 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK091951 HammerlockBiomedical Ent., Inc. · 2010
- Descendant · cites it directly · 7 of its ownK131640 Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK133520 Hammerlock 2Biomedical Enterprises, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK170326 dynaMX Intramedullary ImplantArthrex, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK190287 Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc. · 2019
- Descendant · 5 generations on · 0 of its ownK231147 Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131640Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc. · 2013 · cites it directly7descendants
- K133520Hammerlock 2Biomedical Enterprises, Inc. · 2014 · 2 generations on5descendants
- K170326dynaMX Intramedullary ImplantArthrex, Inc. · 2017 · 3 generations on2descendants
- K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc. · 2019 · 4 generations on1descendant
- K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091951 | Hammerlock | Biomedical Ent., Inc. | 2010 | — |
| +1 | K131640 | Smooth or Threaded Metallic Bone Fastener | Biomedical Ent., Inc. | 2013 | — |
| +2 | K133520 | Hammerlock 2 | Biomedical Enterprises, Inc. | 2014 | — |
| +3 | K170326 | dynaMX Intramedullary Implant | Arthrex, Inc. | 2017 | — |
| +4 | K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | 2019 | — |
| +5 | K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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 |
|---|---|---|---|
| * | — | SmartToe Named without a submission number |
What descends from it? (8)
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?
- Of its descendants, K131640 (Biomedical Ent., Inc., 2013) has gone furthest, with 7 descendants of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The HammerLockTM is indicated for small bone reconstruction and fusion such as in the phalanges of the fingers and toes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091951: Hammerlock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091951
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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