510(k) Report

510(k) · Cleared

Cleared

Nexfix Compression Pin

K072710510(k) TraditionalCleared Nov 8, 200744-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

Nexa Orthopedics, Inc. · JDW Pin, Fixation, Threaded

Cleared on Nov 8, 2007 as substantially equivalent to K051740 (Nexa Orthopedics, Inc., 2005) and 1 other predicate after a 44-day review. Its family tree reaches back 3 generations to 1998. 11 later devices descend from it.

Decided
Nov 8, 2007
Review
44 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K983121 (1998). 11 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedK983121 · Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 · Syntec Scientific Corp. · 1998K993910 · Tac' Pin · New Deal, S.A. · 2000K051740 · Tapered Compression Pin · Nexa Orthopedics, Inc. · 20051995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K051740 · Tapered Compression Pin · Nexa Orthopedics, Inc. · 2005K993910 · Tac' Pin · New Deal, S.A. · 2000K983121 · Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220 · Syntec Scientific Corp. · 19980+5
  1. Root · 3 generations backK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
  2. 2 generations backK993910 Tac' PinNew Deal, S.A. · 2000
  3. 1 generation backK051740 Tapered Compression PinNexa Orthopedics, Inc. · 2005
  4. This deviceK072710 Nexfix Compression PinNexa Orthopedics, Inc. · 2007
  5. Descendant · cites it directly · 10 of its ownK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
  6. Descendant · 2 generations on · 9 of its ownK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
  7. Descendant · 3 generations on · 4 of its ownK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
  8. Descendant · 4 generations on · 3 of its ownK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020
  9. Descendant · 4 generations on · 2 of its ownK213421 Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12014: 12015: 12016: 12019: 12020: 12021: 12022: 12024: 12025: 1
2010high 1 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 11 · See all
  • K100926Arrowhead Fixation DeviceArrow Products, Inc. · 2010 · cites it directly10descendants
  • K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · 2 generations on9descendants
  • K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019 · 3 generations on4descendants
  • K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · 4 generations on3descendants
  • K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K983121Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160…Syntec Scientific Corp.1998—
−2K993910Tac' PinNew Deal, S.A.2000—
−1K051740Tapered Compression PinNexa Orthopedics, Inc.2005—
0 (this device)K072710Nexfix Compression PinNexa Orthopedics, Inc.2007—
+1K100926Arrowhead Fixation DeviceArrow Products, Inc.2010—
+2K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC20111
+3K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC2019—
+4K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.2020—
+4K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201410
201510
201610
201910
202010
202110
202210
202410
202510
FIG. 1 — Lineage of K072710, 1998–2025Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K051740Tapered Compression Pin
Summary page 1
…Orthopedic Regulation Number: 888.3040 Product Code: 87 JDW Predicate Device: 1<1051740, Tapered Compression Pin, Futura Biomedical…
Nexa Orthopedics, Inc.2005—
*K993910Tac' Pin
Summary page 1
…1<1051740, Tapered Compression Pin, Futura Biomedical K'993910 TAC Pin, Newdeal Registration Number: 2030833 Owner Operator Number: 9100540 Dev…
New Deal, S.A.2000—

What descends from it? (11)

See all 11

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100926Arrowhead Fixation DeviceArrow Products, Inc.201010

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 9 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K100926 (Arrow Products, Inc., 2010) has gone furthest, with 10 descendants of its own.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 NexFixTM Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072710: Nexfix Compression Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072710

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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