510(k) · Cleared

Cleared

Biopro Kwick-Wire Universal Screw System

K130298510(k) TraditionalCleared Jun 18, 2013131-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

Biopro, Inc. · JDW Pin, Fixation, Threaded

Cleared on Jun 18, 2013 as substantially equivalent to K991649 (Depuy, Inc., 1999) and 3 other predicates after a 131-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.

Decided: Jun 18, 2013
Review: 131 days
Class: Class II
Product code: JDW
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K962823 (1996). 15 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
3 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
2 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
1 generation backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
This deviceK130298 Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
Descendant · cites it directly · 0 of its ownK142528 AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal…Agent Medical, LLC · 2014
Descendant · cites it directly · 0 of its ownK140875 Optossol Compression Device SystemGenossis, LLC · 2014

Most influential descendants

Showing 2 of 2 · See all

K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC · 2014 · cites it directly0descendants
K140875Optossol Compression Device SystemGenossis, LLC · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K962823	Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer	Synthes (Usa)	1996	—
−3	K993762	I.CO.S Screw	New Deal, S.A.	2000	—
−2	K024233	Kompressor Screw System	Kinetikos Medical, Inc.	2003	—
−1	K040356	Kompressor Screw System	Kinetikos Medical, Inc.	2004	—
0 (this device)	K130298	Biopro Kwick-Wire Universal Screw System	Biopro, Inc.	2013	—
+1	K142528	AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module…	Agent Medical, LLC	2014	—
+1	K140875	Optossol Compression Device System	Genossis, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1990	1	0
1991	1	0
1994	1	0
1996	1	0
1998	1	0
1999	2	0
2002	2	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0

FIG. 1 — Lineage of K130298, 1996–2014Source: 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? (4)

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
*	K991649	Depuy Rockwood Clavicle Pin Summary page 1 …cessories, Class II (21CFR, Sec. 888.3030) DEVICE PRODUCT CODE: JDW SUBSEQUENT PRODUCT CODE: HTN, HWC SUBSTANTIALLY EQUIVALENT DEVICES DePuy — Rockwood Clavicle Pin (K991649) DEVICE DESCRIPTION: Onyx Medical — Hagie Pin (K903258) KMI Kinetikos Medical — Kompressor Compression Screw (K040356) Milleni…	Depuy, Inc.	1999	—
*	K903258	Hagie Pin Summary page 1 …T CODE: JDW SUBSEQUENT PRODUCT CODE: HTN, HWC SUBSTANTIALLY EQUIVALENT DEVICES DePuy — Rockwood Clavicle Pin (K991649) DEVICE DESCRIPTION: Onyx Medical — Hagie Pin (K903258) KMI Kinetikos Medical — Kompressor Compression Screw (K040356) Millenium Medical (now OrthoPediatrics) — PWC Pecutaneous Compre…	Onyx Medical Corp.	1990	—
*	K040356	Kompressor Screw System Summary page 1 …UIVALENT DEVICES DePuy — Rockwood Clavicle Pin (K991649) DEVICE DESCRIPTION: Onyx Medical — Hagie Pin (K903258) KMI Kinetikos Medical — Kompressor Compression Screw (K040356) Millenium Medical (now OrthoPediatrics) — PWC Pecutaneous Compression Wire (K031050) The BioPro Kwick-Wire™ Universal Screw Sys…	Kinetikos Medical, Inc.	2004	—
*	K031050	PCW Percutaneous Compression Wire Summary page 1 …Medical — Hagie Pin (K903258) KMI Kinetikos Medical — Kompressor Compression Screw (K040356) Millenium Medical (now OrthoPediatrics) — PWC Pecutaneous Compression Wire (K031050) The BioPro Kwick-Wire™ Universal Screw System comes in two diameter pin sizes of 2.5mm and 3.0mm and in a length of 4.0in. and…	Millennium Medical Technologies, Inc.	2003	—

Also cleared against K991649: 5 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K142528	AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm	Agent Medical, LLC	2014	0
K140875	Optossol Compression Device System	Genossis, LLC	2014	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?

The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
1 of the 15 ancestors has a recall of any class.
Of its descendants, K142528 (Agent Medical, LLC, 2014) 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. 2013, this device’s year, is highlighted.

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 BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery — but is not intended for Spinal Use.

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/K130298 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130298: Biopro Kwick-Wire Universal 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/K130298

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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