510(k) · Cleared

Cleared

Bosworth Coraco-Clavicular Screw

K023294510(k) SpecialCleared Oct 9, 20027-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

Howmedica Osteonics Corp. · HWC Screw, Fixation, Bone

Cleared on Oct 9, 2002 after a 7-day review. The FDA summary names no predicate by number. 220 later devices descend from it.

Decided: Oct 9, 2002
Review: 7 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

220 later devices descend from it, 2 citing it directly.

This deviceK023294 Bosworth Coraco-Clavicular ScrewHowmedica Osteonics Corp. · 2002
Descendant · cites it directly · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
Descendant · 3 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
Descendant · 2 generations on · 59 of its ownK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
Descendant · 2 generations on · 49 of its ownK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011

Showing 5 of 220 descendants. See all descendants

Descendants cleared per year

2005high 24 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 220 · See all

K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · cites it directly217descendants
K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 3 generations on71descendants
K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008 · 2 generations on59descendants
K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011 · 2 generations on49descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023294	Bosworth Coraco-Clavicular Screw	Howmedica Osteonics Corp.	2002	—
+1	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—
+2	K112437	Arthrex Fracture System	Arthrex, Inc.	2011	—
+3	K123241	Arthrex Fracture Plates	Arthrex, Inc.	2013	—
+2	K082095	Ultraslide Acromioclavicular and Syndesmotic Repair Device	Smith & Nephew Endoscopy, Inc.	2008	—
+2	K112111	Acu-Sinch Repair System and Acumed Suture Anchor	Acumed, LLC	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	2	0
2008	3	0
2009	3	0
2011	6	0
2012	1	0
2013	5	0
2014	14	0
2015	7	0
2016	4	0
2017	11	0
2018	12	0
2019	19	0
2020	16	0
2021	14	0
2022	19	0
2023	15	0
2024	24	0
2025	19	0
2026	23	0

FIG. 1 — Lineage of K023294, 2002–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (220)

See all 220

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

Number	Device	Applicant	Decided	Descendants
K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…	Arthrex, Inc.	2005	217
K063244	Arc Surgical Bone Reduction Screw	Arc Surgical, LLC	2006	1

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, K052776 (Arthrex, Inc., 2005) has gone furthest, with 217 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Bosworth Coraco-Clavicular Screw is intended for uses in cases of acromioclavicular reduction and acromioclavicular fixation; acromioclavicular reduction; coracoclavicular ligament repair, and coracoclavicular fixation; a combination of the aforementioned indications; distal clavicle extension; and muscle transfers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023294: Bosworth Coraco-Clavicular Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023294

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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