510(k) Report

510(k) · Cleared

Cleared

Acumed Clavicle Screw System

K083144510(k) TraditionalCleared Jun 16, 2009236-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

Acumed, LLC · JDW Pin, Fixation, Threaded

Cleared on Jun 16, 2009 as substantially equivalent to K991649 (Depuy, Inc., 1999) and 4 other predicates after a 236-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.

Decided
Jun 16, 2009
Review
236 days
Class
Class II
Product code
JDW
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K903258 (1990). 7 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1998: 1 other ancestor1991: 1 other ancestor2025: 1 descendant clearedK903258 · Hagie Pin · Onyx Medical Corp. · 1990K991649 · Depuy Rockwood Clavicle Pin · Depuy, Inc. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K991649 · Depuy Rockwood Clavicle Pin · Depuy, Inc. · 1999K903258 · Hagie Pin · Onyx Medical Corp. · 19900
  1. Root · 2 generations backK903258 Hagie PinOnyx Medical Corp. · 1990
  2. 1 generation backK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
  3. This deviceK083144 Acumed Clavicle Screw SystemAcumed, LLC · 2009
  4. Descendant · cites it directly · 0 of its ownK242896 Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K903258Hagie PinOnyx Medical Corp.1990—
−1K991649Depuy Rockwood Clavicle PinDepuy, Inc.1999—
0 (this device)K083144Acumed Clavicle Screw SystemAcumed, LLC2009—
+1K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198610
199110
199410
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K083144, 1990–2025Source: 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
Get a 510(k) Report

What was it cleared against? (5)

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
*K991649Depuy Rockwood Clavicle Pin
Summary page 2
…Hillsboro, OR 97124 Phone: (503) 627-9957 Fax: (503) 686-7102 Predicate Device(s): DePuy Rockwood Clavicle Pin - K991649 True/Flex Clavicle Rod System - K934148 Hagie Pin - K903258 Steinmann, Knowles, and Hagie Pins - K863734 Herbert Bone Screw - K79…
Depuy, Inc.1999—
*K934148True/Flex Clavicle Rods
Summary page 2
…Phone: (503) 627-9957 Fax: (503) 686-7102 Predicate Device(s): DePuy Rockwood Clavicle Pin - K991649 True/Flex Clavicle Rod System - K934148 Hagie Pin - K903258 Steinmann, Knowles, and Hagie Pins - K863734 Herbert Bone Screw - K792022 Based upon the similarities of the…
Applied Osteo Systems, Inc.1994—
*K903258Hagie Pin
Summary page 2
…Phone: (503) 627-9957 Fax: (503) 686-7102 Predicate Device(s): DePuy Rockwood Clavicle Pin - K991649 True/Flex Clavicle Rod System - K934148 Hagie Pin - K903258 Steinmann, Knowles, and Hagie Pins - K863734 Herbert Bone Screw - K792022 Based upon the similarities of the Acumed Clavicle Scr…
Onyx Medical Corp.1990—
*K863734Steinmann (Threaded/Calibrated),Knowles&Hogie Pins
Summary page 2
…3) 686-7102 Predicate Device(s): DePuy Rockwood Clavicle Pin - K991649 True/Flex Clavicle Rod System - K934148 Hagie Pin - K903258 Steinmann, Knowles, and Hagie Pins - K863734 Herbert Bone Screw - K792022 Based upon the similarities of the Acumed Clavicle Screw System and the predicated devices studied,…
Micro-Aire Surgical Instruments, Inc.19861
*K792022Herbert Bone Screw
Summary page 2
…e(s): DePuy Rockwood Clavicle Pin - K991649 True/Flex Clavicle Rod System - K934148 Hagie Pin - K903258 Steinmann, Knowles, and Hagie Pins - K863734 Herbert Bone Screw - K792022 Based upon the similarities of the Acumed Clavicle Screw System and the predicated devices studied, the safety and effectiveness…
Zimmer, Inc.19796

Also cleared against K991649: 5 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies20250

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 19 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K242896 (Nvision Biomedical Technologies, 2025) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K991649.

How does its category compare?

All JDW devices

JDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Acumed Clavicle Screw System is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Indications for use as stated in the FDA summary.

Also cleared against K991649

5 other devices cite the same predicate.

  • K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
  • K111550Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia, Yyy=Length- in MM)Sonoma Orthopedic Products, Inc. · 2011
  • K103001Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011
  • K100112Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM)Sonoma Orthopedic Products, Inc. · 2010
  • K081832Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008

More from Acumed, LLC

38 FDA decisions under this applicant name. See the company

  • K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC · 2025
  • K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC · 20251 recall
  • K251296The Acumed Wrist Fixation SystemAcumed, LLC · 20251 recall
  • K243624Acu-Sinch Knotless MiniAcumed, LLC · 2025
  • K233311Acumed Wrist Plating SystemAcumed, LLC · 2024

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/K083144 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083144: Acumed Clavicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083144

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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