510(k) · Cleared

Cleared

Medline Cannulated Screw

K130319510(k) TraditionalCleared May 31, 2013112-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

Medline Industries, Inc. · HWC Screw, Fixation, Bone

Cleared on May 31, 2013 as substantially equivalent to K082320 (Wrightmedicaltechnologyinc, 2008) after a 112-day review. Its family tree reaches back 1 generation to 2008. 12 later devices descend from it.

Decided: May 31, 2013
Review: 112 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K082320 (2008). 12 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK082320 Darco Small ScrewWrightmedicaltechnologyinc · 2008
This deviceK130319 Medline Cannulated ScrewMedline Industries, Inc. · 2013
Descendant · cites it directly · 2 of its ownK181820 Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018
Descendant · cites it directly · 1 of its ownK241359 Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP · 2024
Descendant · cites it directly · 1 of its ownK234031 Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024
Descendant · cites it directly · 1 of its ownK211612 Medline UNITE REFLEX Dynamic DiscsMedline Industries, Inc. · 2021
Descendant · cites it directly · 1 of its ownK162829 Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2016high 2 (2021) · low 0 (2019)2026

Most influential descendants

Showing 5 of 12 · See all

K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc. · 2018 · cites it directly2descendants
K241359Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP · 2024 · cites it directly1descendant
K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP · 2024 · cites it directly1descendant
K211612Medline UNITE REFLEX Dynamic DiscsMedline Industries, Inc. · 2021 · cites it directly1descendant
K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. · 2016 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K082320	Darco Small Screw	Wrightmedicaltechnologyinc	2008	—
0 (this device)	K130319	Medline Cannulated Screw	Medline Industries, Inc.	2013	—
+1	K181820	Medline Unite Mini Plates and Screws	Medline Industries, Inc.	2018	—
+1	K241359	Medline UNITE® MIS Foot Recon Screw System	Medline Industries, LP	2024	—
+1	K234031	Medline UNITE Ancillary Foot Recon Plating System	Medline Industires, LP	2024	—
+1	K211612	Medline UNITE REFLEX Dynamic Discs	Medline Industries, Inc.	2021	—
+1	K162829	Medline UNITE® Ankle Fracture Plating System	Medline Industries, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0
2018	1	0
2020	1	0
2021	2	0
2022	2	0
2024	2	0
2025	2	0

FIG. 1 — Lineage of K130319, 2008–2025Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (1)

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
*	K082320	Darco Small Screw Summary page 1 …ame: Bone Screw Classification Name: Screw, Fixation, Bone (21 CFR 888.3040, product code - HWC) Predicate Device (primary) Wright Compression Screws (Wright Medical), K082320 Device Description TeMedline Cannulated Screws are manufactured from titanium alloy or stainless steel. The screws are offere…	Wrightmedicaltechnologyinc	2008	—

Also cleared against K082320: 17 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K181820	Medline Unite Mini Plates and Screws	Medline Industries, Inc.	2018	2
K241359	Medline UNITE® MIS Foot Recon Screw System	Medline Industries, LP	2024	1
K234031	Medline UNITE Ancillary Foot Recon Plating System	Medline Industires, LP	2024	1
K211612	Medline UNITE REFLEX Dynamic Discs	Medline Industries, Inc.	2021	1
K162829	Medline UNITE® Ankle Fracture Plating System	Medline Industries, Inc.	2016	1
K220511	Medline UNITE IM Fibula Implant	Medline Industries, LP	2022	0
K211944	Medline UNITE® Digital Fusion Screw System	Medline Industries, Inc.	2021	0
K201319	Medline UNITE Jones Fracture Screw System	Medline Industires, Inc.	2020	0
K170782	Medline UNITE® Snap-Off Screws	Medline Industries, Inc.	2017	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?

Its one ancestor has no recall.
Of its descendants, K181820 (Medline Industries, Inc., 2018) has gone furthest, with 2 descendants of its own.
17 other devices also cite its predicate K082320.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

The Medline Cannulated Screws are indicated for use in bone reconstruction,

osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones

appropriate for the size of the device. Screws are intended for single use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130319 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130319: Medline Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130319

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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