510(k) · Cleared
ClearedTac' Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · JDW Pin, Fixation, Threaded
Cleared on Feb 1, 2000 as substantially equivalent to K983121 (Syntec Scientific Corp., 1998) after a 76-day review. Its family tree reaches back 1 generation to 1998. 14 later devices descend from it.
- Decided
- Feb 1, 2000
- Review
- 76 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983121 (1998). 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
- This deviceK993910 Tac' PinNew Deal, S.A. · 2000
- Descendant · cites it directly · 12 of its ownK051740 Tapered Compression PinNexa Orthopedics, Inc. · 2005
- Descendant · cites it directly · 11 of its ownK072710 Nexfix Compression PinNexa Orthopedics, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
- Descendant · 3 generations on · 9 of its ownK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
- Descendant · 4 generations on · 4 of its ownK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K051740Tapered Compression PinNexa Orthopedics, Inc. · 2005 · cites it directly12descendants
- K072710Nexfix Compression PinNexa Orthopedics, Inc. · 2007 · cites it directly11descendants
- K100926Arrowhead Fixation DeviceArrow Products, Inc. · 2010 · 2 generations on10descendants
- K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · 3 generations on9descendants
- K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… | Syntec Scientific Corp. | 1998 | — |
| 0 (this device) | K993910 | Tac' Pin | New Deal, S.A. | 2000 | — |
| +1 | K051740 | Tapered Compression Pin | Nexa Orthopedics, Inc. | 2005 | — |
| +1 | K072710 | Nexfix Compression Pin | Nexa Orthopedics, Inc. | 2007 | — |
| +2 | K100926 | Arrowhead Fixation Device | Arrow Products, Inc. | 2010 | — |
| +3 | K112675 | Arrow-Lok Digital System | Arrowhead Medical Device Technologies, LLC | 2011 | 1 |
| +4 | K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K082931 | Threaded fixation pin manufactured by Sgarlato Laboratories Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…Summary page 2…Threaded fixation pin manufactured by Sgarlato laboratories (’_ 82931), and the Kirschner wires and Steitnmann pins manufactured by Syntec-Taichung Medical Instruments (K983121). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Both the TAC’pin®, the Sgarlato threaded fixation pin, and the Kirschner wires an… | 1998 |
What descends from it? (14)
See all 143 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?
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TAC’pin® is indicated for synthesis of small bones fragments, in the foot only. Examples include:
-Akin type osteotomy
-first MP Arthrodesis
-phalangeal arthrodesis
-small bones osteosynthesis requiring compression.
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/K993910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993910: Tac' Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993910
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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