510(k) · Cleared

Cleared

2.0/2.4 Cannulated Screw System

K010783510(k) TraditionalCleared May 30, 200176-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

Osteomed Corp. · HWC Screw, Fixation, Bone

Cleared on May 30, 2001 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 484 later devices descend from it.

Decided: May 30, 2001
Review: 76 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 0

484 later devices descend from it, 4 citing it directly.

This deviceK010783 2.0/2.4 Cannulated Screw SystemOsteomed Corp. · 2001
Descendant · cites it directly · 310 of its ownK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
Descendant · 2 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
Descendant · cites it directly · 145 of its ownK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
Descendant · 2 generations on · 144 of its ownK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
Descendant · 3 generations on · 143 of its ownK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011

Showing 5 of 484 descendants. See all descendants

Descendants cleared per year

2005high 58 (2026) · low 0 (2007)2026

Most influential descendants

Showing 5 of 484 · See all

K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006 · cites it directly310descendants
K103705Low Profile ScrewsArthrex, Inc. · 2011 · 2 generations on219descendants
K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · cites it directly145descendants
K080398SI Joint Fusion SystemSI-BONE, Inc. · 2008 · 2 generations on144descendants
K110838Ifuse Implant SystemSI-BONE, Inc. · 2011 · 3 generations on143descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010783	2.0/2.4 Cannulated Screw System	Osteomed Corp.	2001	—
+1	K062863	Osteomed Extended 2.0/2.4CANNULATED Screw System	Osteomed LP	2006	—
+2	K103705	Low Profile Screws	Arthrex, Inc.	2011	—
+1	K051309	Roi Fusion Rods & Plates	Reiley Orthopaedics, Inc.	2005	2
+2	K080398	SI Joint Fusion System	SI-BONE, Inc.	2008	—
+3	K110838	Ifuse Implant System	SI-BONE, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	1	0
2009	1	0
2010	2	0
2011	10	0
2012	10	0
2013	13	0
2014	20	0
2015	29	0
2016	12	0
2017	34	0
2018	17	0
2019	23	0
2020	31	0
2021	34	0
2022	42	0
2023	50	0
2024	47	0
2025	48	0
2026	58	0

FIG. 1 — Lineage of K010783, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (484)

See all 484

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

Number	Device	Applicant	Decided	Descendants
K062863	Osteomed Extended 2.0/2.4CANNULATED Screw System	Osteomed LP	2006	310
K051309	Roi Fusion Rods & Plates	Reiley Orthopaedics, Inc.	2005	145
K101030	Modification to HBS Headless Bone Screw	Biopro, Inc.	2010	40
K120493	Mini Cannulated Headed and Headless Screw Set	Instratek, Inc.	2012	39

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, K062863 (Osteomed LP, 2006) has gone furthest, with 310 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	—

https://510kreport.com/device/K010783 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010783: 2.0/2.4 Cannulated 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/K010783

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026