510(k) · Cleared

Cleared

Cannulated Screw

K161058510(k) TraditionalCleared Jul 29, 2016105-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

Miami Device Solutions, LLC · HWC Screw, Fixation, Bone

Cleared on Jul 29, 2016 as substantially equivalent to K141493 (Miami Device Solutions, 2015) and 7 other predicates after a 105-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.

Decided: Jul 29, 2016
Review: 105 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 8

Its longest line of descent runs back 8 generations to K962616 (1996). 48 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
1 generation backK141493 Proximal Humerus Plating SystemMiami Device Solutions · 2015 · Recalled
This deviceK161058 Cannulated ScrewMiami Device Solutions, LLC · 2016
Descendant · cites it directly · 0 of its ownK173556 Injection ScrewBiedermann Medtech, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K173556Injection ScrewBiedermann Medtech, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K962616	Synthes Dorsal Distal Radius Plate (DDRP) System	Synthes (Usa)	1996	—
−7	K982732	Synthes (Usa) Distal Radius Plate System (DRPS)	Synthes	1998	—
−6	K023007	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2002	—
−5	K030198	Hand Innovations, Inc. Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−4	K032705	Distal Radius Fracture Repair System	Hand Innovations, Inc.	2003	—
−3	K050932	Distal Volar Radius Anatomical Plate System	Hand Innovations, Inc.	2005	1
−2	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
−1	K141493	Proximal Humerus Plating System	Miami Device Solutions	2015	1
0 (this device)	K161058	Cannulated Screw	Miami Device Solutions, LLC	2016	—
+1	K173556	Injection Screw	Biedermann Medtech, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1995	1	0
1996	2	0
1998	3	0
1999	2	0
2000	6	0
2001	7	0
2003	3	0
2004	9	0
2005	3	0
2006	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K161058, 1996–2018Source: 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? (8)

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
*	K141493	Proximal Humerus Plating System Summary page 4 …ie, PhD Phone Number: (514) 901-0796; (973) 738-6097 Fax Number: (514) 901-0796 Date of Submission: July 28, 2016 C.1. PREDICATE DEVICES K141493 Miami Device Solutions, LLC Proximal Humerus Plating System K041965 Arthrex Inc., Arthrex Humera…	Miami Device Solutions	2015	1
*	K041965	Arthrex Humeral Fracture Plates and Screws Summary page 4 …(514) 901-0796 Date of Submission: July 28, 2016 C.1. PREDICATE DEVICES K141493 Miami Device Solutions, LLC Proximal Humerus Plating System K041965 Arthrex Inc., Arthrex Humeral Fracture Plates & Screws K040593, K042598, Zimmer, Inc. Proximal Humeral Pla…	Arthrex, Inc.	2004	—
*	K040593	Periarticular Locking Plates and Screws, 2358, 2359 Series Summary page 4 …CES K141493 Miami Device Solutions, LLC Proximal Humerus Plating System K041965 Arthrex Inc., Arthrex Humeral Fracture Plates & Screws K040593, K042598, Zimmer, Inc. Proximal Humeral Plating System K043227, K043560, K050121, K051098 July 28, 2016…	Zimmer, Inc.	2004	2
*	K042598	Periarticular Locking Plates and Screws, 2357 and 2359 Series Summary page 4 …493 Miami Device Solutions, LLC Proximal Humerus Plating System K041965 Arthrex Inc., Arthrex Humeral Fracture Plates & Screws K040593, K042598, Zimmer, Inc. Proximal Humeral Plating System K043227, K043560, K050121, K051098 July 28, 2016…	Zimmer, Inc.	2004	1
*	K043227	Periarticular Locking Plates, 2358 Series Summary page 4 …rus Plating System K041965 Arthrex Inc., Arthrex Humeral Fracture Plates & Screws K040593, K042598, Zimmer, Inc. Proximal Humeral Plating System K043227, K043560, K050121, K051098 July 28, 2016 Page 1 of 3 ==…	Zimmer, Inc.	2004	—
*	K043560	Periarticular Locking Plates and Screws, Series 2358 and 2359 Summary page 4 …ng System K041965 Arthrex Inc., Arthrex Humeral Fracture Plates & Screws K040593, K042598, Zimmer, Inc. Proximal Humeral Plating System K043227, K043560, K050121, K051098 July 28, 2016 Page 1 of 3 === Page 5…	Zimmer, Inc.	2005	—
*	K050121	Zimmer Periarticular Locking Plate System, Model 2357 & 2359 Summary page 4 …K041965 Arthrex Inc., Arthrex Humeral Fracture Plates & Screws K040593, K042598, Zimmer, Inc. Proximal Humeral Plating System K043227, K043560, K050121, K051098 July 28, 2016 Page 1 of 3 K16105…	Zimmer, Inc.	2005	—
*	K051098	Periarticular Locking Plates and Screws, Model 2358 Series Summary page 4 …Arthrex Inc., Arthrex Humeral Fracture Plates & Screws K040593, K042598, Zimmer, Inc. Proximal Humeral Plating System K043227, K043560, K050121, K051098 July 28, 2016 Page 1 of 3 K161058…	Zimmer, Inc.	2005	—
†	K151418	Monster Screw System	Paragon 28	2015	—

Also cleared against K141493: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K173556	Injection Screw	Biedermann Medtech, Inc.	2018	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 20 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
14 of the 48 ancestors have a recall of any class.
Of its descendants, K173556 (Biedermann Medtech, Inc., 2018) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K141493.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

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/K161058 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161058: 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/K161058

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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