510(k) · Cleared
ClearedHammerlock 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Enterprises, Inc. · HTY Pin, Fixation, Smooth
Cleared on Jan 9, 2014 as substantially equivalent to K131640 (Biomedical Ent., Inc., 2013) after a 55-day review. Its family tree reaches back 4 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 9, 2014
- Review
- 55 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960385 (1996). 7 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 3 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 2 generations backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- 1 generation backK131640 Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc. · 2013
- This deviceK133520 Hammerlock 2Biomedical Enterprises, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK170326 dynaMX Intramedullary ImplantArthrex, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK190287 Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK231147 Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023
- Descendant · cites it directly · 0 of its ownK191463 DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK152627 IFS Fixation Scaffold SystemMetric Medical Devices, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K170326dynaMX Intramedullary ImplantArthrex, Inc. · 2017 · cites it directly2descendants
- K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc. · 2019 · 2 generations on1descendant
- K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023 · 3 generations on0descendants
- K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC · 2020 · cites it directly0descendants
- K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −3 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −2 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| −1 | K131640 | Smooth or Threaded Metallic Bone Fastener | Biomedical Ent., Inc. | 2013 | — |
| 0 (this device) | K133520 | Hammerlock 2 | Biomedical Enterprises, Inc. | 2014 | — |
| +1 | K170326 | dynaMX Intramedullary Implant | Arthrex, Inc. | 2017 | — |
| +2 | K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | 2019 | — |
| +3 | K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023 | — |
| +1 | K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | 2020 | 2 |
| +1 | K152627 | IFS Fixation Scaffold System | Metric Medical Devices, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131640 | Smooth or Threaded Metallic Bone FastenerSummary page 1…h as inter-digital fusion of fingers and toes. Substantial Equivalence: The HammerLock® 2 is substantially equivalent to the predicate BME HammerLock® cleared in K 131640. Device Description The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for… | 2013 |
| † | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | 2007 |
What descends from it? (5)
3 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 18 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K170326 (Arthrex, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K131640.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 HammerLock® 2 is indicated for:
Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133520: Hammerlock 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133520
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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