510(k) Report

510(k) · Cleared

Cleared

Apex Pins

K061493510(k) TraditionalCleared Jul 7, 200637-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

Stryker Howmedica Osteonics · JDW Pin, Fixation, Threaded

Cleared on Jul 7, 2006 after a 37-day review. The FDA summary names no predicate by number. 12 later devices descend from it.

Decided
Jul 7, 2006
Review
37 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
0

12 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2025: 4 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared2014: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK061493 Apex PinsStryker Howmedica Osteonics · 2006
  2. Descendant · cites it directly · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
  3. Descendant · 2 generations on · 4 of its ownK163487 Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017
  4. Descendant · 3 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
  5. Descendant · cites it directly · 1 of its ownK211112 OIC External Fixation SystemOrthopaedic Implant Company · 2021
  6. Descendant · 2 generations on · 1 of its ownK202054 Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2014: 12017: 22018: 12020: 12021: 12024: 12025: 42026: 1
2014high 4 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 12 · See all
  • K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · cites it directly5descendants
  • K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017 · 2 generations on4descendants
  • K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 3 generations on1descendant
  • K211112OIC External Fixation SystemOrthopaedic Implant Company · 2021 · cites it directly1descendant
  • K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061493Apex PinsStryker Howmedica Osteonics2006—
+1K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.2014—
+2K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.2017—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.2025—
+1K211112OIC External Fixation SystemOrthopaedic Implant Company2021—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201720
201810
202010
202110
202410
202540
202610
FIG. 1 — Lineage of K061493, 2006–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (12)

See all 12

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145
K211112OIC External Fixation SystemOrthopaedic Implant Company20211
K260900DYNEX® External Fixation SystemsVilex, LLC20260
K253202Hoffmann LRF SystemStryker GmbH20250
K250315Ronavis – FX (FX-001)AIRS, Inc.20250
K172438ARBOR External Fixation SystemGlobus Medical, Inc.20180
K171211OIC External Fixation SystemOrthopaedic Implant Company20170

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?

  • Of its descendants, K132820 (Vilex, Inc., 2014) has gone furthest, with 5 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.

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?

Apex® Pins are intended for use in conjunction with external fixators in children and adults. Specific indications include, but not limited to the following conditions: bone fracture fixation for open, closed and/or unstable fractures, osteotomies, arthrodeses, deformity correction including bone transport, revision procedures where other treatments or devices have been unsuccessful or bone reconstruction procedures. The pins will be available with and without hydroxylapatite (HA) coating.

Indications for use as stated in the FDA summary.

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/K061493 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061493: Apex Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061493

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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