510(k) Report

510(k) · Cleared

Cleared

T-PIN

K053513510(k) TraditionalCleared Jan 13, 200628-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Union Surgical, LLC · JDW Pin, Fixation, Threaded

Cleared on Jan 13, 2006 as substantially equivalent to K032532 (Union Surgical, LLC, 2003) after a 28-day review. Its family tree reaches back 1 generation to 2003.

Decided
Jan 13, 2006
Review
28 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K032532 (2003). No later device cites it as a predicate yet.

K032532 · Taras Threaded Fixation Pin · Union Surgical, LLC · 200320002002200420062008
K032532 · Taras Threaded Fixation Pin · Union Surgical, LLC · 20030
  1. Root · 1 generation backK032532 Taras Threaded Fixation PinUnion Surgical, LLC · 2003
  2. This deviceK053513 T-PINUnion Surgical, LLC · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K032532Taras Threaded Fixation PinUnion Surgical, LLC2003—
0 (this device)K053513T-PINUnion Surgical, LLC2006—
FIG. 1 — Lineage of K053513, 2003–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K032532Taras Threaded Fixation Pin
Summary page 1
…LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pin that is legally marketed and distributed by Union Surgical, LLC pursuant to K032532. Device Description The Union Surgical. LLC T-Pin® is a threaded and cannulated stainless steel Steinmann…
Union Surgical, LLC2003—

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?

  • Its one ancestor has no recall.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDW

2in 2025

2007: 22009: 12010: 22011: 12012: 12013: 22014: 22015: 12017: 12018: 12019: 12020: 22021: 22022: 22025: 22026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

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

2009: 22010: 22012: 522017: 22018: 21
2007high 52 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDW

29in 2025

2007: 252008: 262009: 292010: 292011: 552012: 752013: 692014: 272015: 702016: 462017: 432018: 942019: 5752020: 4022021: 1682022: 1212023: 722024: 652025: 29
2007high 575 (2019) · low 25 (2007)2025

MAUDE reports naming product code JDW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—025
20080—026
20091—229
20102—229
20111—055
20121—5275
20132—069
20142—027
20151—070
20160—046
20171—243
20181—2194
20191—0575
20202—0402
20212—0168
20222—0121
20230—072
20240—065
20252—029
20261—0—

What is it indicated for?

The Union Surgical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

Indications for use as stated in the FDA summary.

More from Union Surgical, LLC

2 FDA decisions under this applicant name. See the company

  • K032532Taras Threaded Fixation PinUnion Surgical, LLC · 2003

Recent decisions in JDW

The JDW category page

  • K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
  • K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC · 2025
  • K241357XT3 SystemBiodynamik, Inc. · 2025
  • K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
  • K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022

https://510kreport.com/device/K053513 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053513: T-PIN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053513

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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