510(k) · Cleared
ClearedModification to the Tac' 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 Sep 6, 2001 as substantially equivalent to K993910 (New Deal, S.A., 2000) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Sep 6, 2001
- Review
- 83 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K983121 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… | Syntec Scientific Corp. | 1998 | — |
| −1 | K993910 | Tac' Pin | New Deal, S.A. | 2000 | — |
| 0 (this device) | K011875 | Modification to the Tac' Pin | New Deal, S.A. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (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 |
|---|---|---|---|
| * | K993910 | Tac' PinSummary page 2…steotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) PREDICATE DEVICE The “new” TAC’pin® is technically equivalent to the TAC’pin® currently approved (K993910). The “new” TAC’pin® is substantially equivalent to the Threaded fixation pin manufactured by Sgarlato laboratories (K982931), an… | 2000 |
| * | K982931 | Threaded Fixation PinSummary page 2…uivalent to the TAC’pin® currently approved (K993910). The “new” TAC’pin® is substantially equivalent to the Threaded fixation pin manufactured by Sgarlato laboratories (K982931), and the Kirschner wires and Steinmann pins manufactured by Syntec- Taichung Medical Instruments (K983121). COMPARISON OF TECHN… | 1998 |
| * | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…Summary page 2…e Threaded fixation pin manufactured by Sgarlato laboratories (K982931), and the Kirschner wires and Steinmann pins manufactured by Syntec- Taichung Medical Instruments (K983121). COMPARISON OF TECHNOLOGICAL CHARACTERISTICS The “new” TAC’pin®:is technically equivalent to the device currently approved. Th… | 1998 |
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 3 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K993910.
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 “new” TAC’pin® is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
Fixation of small bone fragments, in long bones or small bones fractures.
Arthrodesis in hand or foot surgery
Mono or Bi-cortical osteotomies in the foot or hand
Distal or proximal metatarsal or metacarpal osteotomies
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
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/K011875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011875: Modification to the Tac' Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011875
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026