510(k) · Cleared

Cleared

Depuy Rockwood Clavicle Pin

K991649510(k) TraditionalCleared Jul 14, 199962-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

Depuy, Inc. · JDW Pin, Fixation, Threaded

Cleared on Jul 14, 1999 as substantially equivalent to K903258 (Onyx Medical Corp., 1990) and 2 other predicates after a 62-day review. Its family tree reaches back 1 generation to 1990. 15 later devices descend from it.

Decided: Jul 14, 1999
Review: 62 days
Class: Class II
Product code: JDW
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K903258 (1990). 3 ancestors in all. 15 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK903258 Hagie PinOnyx Medical Corp. · 1990
This deviceK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
Descendant · cites it directly · 7 of its ownK103001 Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011
Descendant · cites it directly · 4 of its ownK081832 Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008
Descendant · 2 generations on · 2 of its ownK143204 AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015
Descendant · cites it directly · 2 of its ownK130298 Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
Descendant · cites it directly · 2 of its ownK100112 Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy…Sonoma Orthopedic Products, Inc. · 2010

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2008high 2 (2011) · low 0 (2016)2026

Most influential descendants

Showing 5 of 15 · See all

K103001Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011 · cites it directly7descendants
K081832Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008 · cites it directly4descendants
K143204AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015 · 2 generations on2descendants
K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013 · cites it directly2descendants
K100112Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM)Sonoma Orthopedic Products, Inc. · 2010 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903258	Hagie Pin	Onyx Medical Corp.	1990	—
0 (this device)	K991649	Depuy Rockwood Clavicle Pin	Depuy, Inc.	1999	—
+1	K103001	Rockwood Clavicle Pins	DePuy Orthopaedics, Inc.	2011	—
+1	K081832	Ensplintcmx Clavicle Pin	Sonoma Orthopedic Products, Inc.	2008	—
+2	K143204	AOS Clavicle Intramedullary Device	Advanced Orthopaedic Solutions, Inc.	2015	—
+1	K130298	Biopro Kwick-Wire Universal Screw System	Biopro, Inc.	2013	—
+1	K100112	Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia…	Sonoma Orthopedic Products, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2014	2	0
2015	1	0
2017	1	0
2020	2	0
2025	2	0

FIG. 1 — Lineage of K991649, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K903258	Hagie Pin Summary page 1 …040, Smooth or threaded metallic bone fixation fastener 87 IDW DePuy Hagie & Modified Hagie Pins (pre-enactment) DePuy Tibia Bolt (pre-enactment) Onyx Medical Corp. (K903258) and O’Tec Corp. (K905347) Hagie Pins Syntec-Trichung Knowles Pin (K983757) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Roc…	Onyx Medical Corp.	1990	—
*	K905347	Hagie Pin Summary page 1 …tallic bone fixation fastener 87 IDW DePuy Hagie & Modified Hagie Pins (pre-enactment) DePuy Tibia Bolt (pre-enactment) Onyx Medical Corp. (K903258) and O’Tec Corp. (K905347) Hagie Pins Syntec-Trichung Knowles Pin (K983757) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Rockwood Clavicle Pin consist…	O'Tec Corp.	1991	—
*	K983757	Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar… Summary page 1 …& Modified Hagie Pins (pre-enactment) DePuy Tibia Bolt (pre-enactment) Onyx Medical Corp. (K903258) and O’Tec Corp. (K905347) Hagie Pins Syntec-Trichung Knowles Pin (K983757) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Rockwood Clavicle Pin consists of three sub-components, a pin and two nuts, and…	Syntec Scientific Corp.	1998	—
*	—	DePuy Hagie & Modified Hagie Pins (pre-enactment) Named without a submission number			—
*	—	DePuy Tibia Bolt (pre-enactment) Named without a submission number			—

Also cleared against K903258: 2 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K103001	Rockwood Clavicle Pins	DePuy Orthopaedics, Inc.	2011	7
K081832	Ensplintcmx Clavicle Pin	Sonoma Orthopedic Products, Inc.	2008	4
K130298	Biopro Kwick-Wire Universal Screw System	Biopro, Inc.	2013	2
K100112	Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM)	Sonoma Orthopedic Products, Inc.	2010	2
K083144	Acumed Clavicle Screw System	Acumed, LLC	2009	1
K111550	Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia…	Sonoma Orthopedic Products, Inc.	2011	0

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?

None of the 3 ancestors has a recall.
Of its descendants, K103001 (DePuy Orthopaedics, Inc., 2011) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K903258.

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

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

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

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

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 DePuy Rockwood Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

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/K991649 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991649: Depuy Rockwood Clavicle Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991649

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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