510(k) · Cleared
ClearedSmooth or Threaded Metallic Bone Fastener
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 Oct 16, 2013 as substantially equivalent to K091951 (Biomedical Ent., Inc., 2010) and 1 other predicate after a 134-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it.
- Decided
- Oct 16, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960385 (1996). 6 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- This deviceK131640 Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc. · 2013
- Descendant · cites it directly · 5 of its ownK133520 Hammerlock 2Biomedical Enterprises, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK170326 dynaMX Intramedullary ImplantArthrex, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK190287 Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK231147 Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023
- Descendant · 2 generations on · 0 of its ownK191463 DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC · 2020 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133520Hammerlock 2Biomedical Enterprises, Inc. · 2014 · cites it directly5descendants
- K170326dynaMX Intramedullary ImplantArthrex, Inc. · 2017 · 2 generations on2descendants
- K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc. · 2019 · 3 generations on1descendant
- K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation · 2023 · 4 generations on0descendants
- K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| 0 (this device) | K131640 | Smooth or Threaded Metallic Bone Fastener | Biomedical Ent., Inc. | 2013 | — |
| +1 | K133520 | Hammerlock 2 | Biomedical Enterprises, Inc. | 2014 | — |
| +2 | K170326 | dynaMX Intramedullary Implant | Arthrex, Inc. | 2017 | — |
| +3 | K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex, Inc. | 2019 | — |
| +4 | K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023 | — |
| +2 | K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | 2020 | 2 |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K091951 | HammerlockSummary page 1…ital fusion of fingers and toes. Substantial Equivalence: The upgraded Hamnmerlock is substantially equivalent to the predicate BME Hamnmerlock cleared in K091951. Device Description The Hamnmerlock is a nitinol implant that comes in a range of sizes to provide intramedullary… | 2010 |
| * | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseSummary page 2…d to compare the corrosion resistance of representative samples of the new Hammerlock to technical literature and to predicate SmartToes devices (K070598). The test results demonstrate that the Hamnmerlock corrosion resistance is adequate according to technical literatur… | 2007 |
What descends from it? (7)
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 17 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K133520 (Biomedical Enterprises, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K091951.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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®R 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/K131640 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131640: Smooth or Threaded Metallic Bone Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131640
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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