510(k) · Cleared

Cleared

Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar: 2991-01/15,2992-01/15, for Square Collar:29992-01

K983757510(k) TraditionalCleared Dec 4, 199842-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

Syntec Scientific Corp. · JDW Pin, Fixation, Threaded

Cleared on Dec 4, 1998 after a 42-day review. The FDA summary names no predicate by number. 16 later devices descend from it.

Decided: Dec 4, 1998
Review: 42 days
Class: Class II
Product code: JDW
Recalls: None
Predicates: 0

16 later devices descend from it, 1 citing it directly.

This deviceK983757 Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal…Syntec Scientific Corp. · 1998
Descendant · cites it directly · 15 of its ownK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
Descendant · 2 generations on · 7 of its ownK103001 Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK081832 Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008
Descendant · 3 generations on · 2 of its ownK143204 AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015
Descendant · 2 generations on · 2 of its ownK130298 Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1999high 2 (2011) · low 0 (2000)2026

Most influential descendants

Showing 5 of 16 · See all

K991649Depuy Rockwood Clavicle PinDepuy, Inc. · 1999 · cites it directly15descendants
K103001Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011 · 2 generations on7descendants
K081832Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008 · 2 generations on4descendants
K143204AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015 · 3 generations on2descendants
K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K983757	Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar…	Syntec Scientific Corp.	1998	—
+1	K991649	Depuy Rockwood Clavicle Pin	Depuy, Inc.	1999	—
+2	K103001	Rockwood Clavicle Pins	DePuy Orthopaedics, Inc.	2011	—
+2	K081832	Ensplintcmx Clavicle Pin	Sonoma Orthopedic Products, Inc.	2008	—
+3	K143204	AOS Clavicle Intramedullary Device	Advanced Orthopaedic Solutions, Inc.	2015	—
+2	K130298	Biopro Kwick-Wire Universal Screw System	Biopro, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
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 K983757, 1998–2025Source: 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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K991649	Depuy Rockwood Clavicle Pin	Depuy, Inc.	1999	15

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, K991649 (Depuy, Inc., 1999) has gone furthest, with 15 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

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 Knowles Pin is provided non-sterile. The device may be used for bone reconstruction, for reducible intracapsular fracture of the femoral neck and to moderate slipped upper femoral epiphyses.

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/K983757 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983757: Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar: 2991-01/15,2992-01/15, for Square Collar:29992-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983757

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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