510(k) · Cleared

Cleared

Ortho-Pro Cannulated Bone Screws

K042310510(k) TraditionalCleared Sep 16, 200422-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

Ortho-Pro, LLC · HWC Screw, Fixation, Bone

Cleared on Sep 16, 2004 as substantially equivalent to K991151 (Vilex, Inc., 1999) after a 22-day review. Its family tree reaches back 1 generation to 1999. 20 later devices descend from it.

Decided: Sep 16, 2004
Review: 22 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K991151 (1999). 20 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK991151 Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex…Vilex, Inc. · 1999
This deviceK042310 Ortho-Pro Cannulated Bone ScrewsOrtho-Pro, LLC · 2004
Descendant · cites it directly · 11 of its ownK143460 Cannulated Screw SystemWrightmedicaltechnologyinc · 2015
Descendant · 2 generations on · 7 of its ownK180377 Fracture and Correction SystemIn2bones USA, LLC · 2018
Descendant · cites it directly · 5 of its ownK061620 Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006
Descendant · cites it directly · 4 of its ownK161904 GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017
Descendant · 2 generations on · 4 of its ownK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2006high 3 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 20 · See all

K143460Cannulated Screw SystemWrightmedicaltechnologyinc · 2015 · cites it directly11descendants
K180377Fracture and Correction SystemIn2bones USA, LLC · 2018 · 2 generations on7descendants
K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006 · cites it directly5descendants
K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC · 2017 · cites it directly4descendants
K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991151	Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated…	Vilex, Inc.	1999	—
0 (this device)	K042310	Ortho-Pro Cannulated Bone Screws	Ortho-Pro, LLC	2004	—
+1	K143460	Cannulated Screw System	Wrightmedicaltechnologyinc	2015	—
+2	K180377	Fracture and Correction System	In2bones USA, LLC	2018	—
+1	K061620	Ifs Cannulated Bone Screw	Internal Fixation Systems, Inc.	2006	—
+1	K161904	GEO Bone Screw System	Gramercy Extremity Orthopeidics, LLC	2017	—
+2	K063589	Gso Bone Fixation Fasteners	Gold Standard Orthopaedics, LLC	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2014	2	0
2015	1	0
2017	2	0
2018	1	0
2019	1	0
2020	3	0
2021	1	0
2022	1	0
2023	2	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K042310, 1999–2026Source: 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? (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
*	K991151	Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw Summary page 1 …ws Common name Bone screw Classification name Class II per 21 CFR section 888.3040 Product Code HWC Equivalent Device Vilex Cannulated Screws (K991151). Device Description The Ortho-Pro Cannulated Bone Screw consists of a threaded implant and corresponding instrumentation to fac…	Vilex, Inc.	1999	—

Also cleared against K991151: 9 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K143460	Cannulated Screw System	Wrightmedicaltechnologyinc	2015	11
K061620	Ifs Cannulated Bone Screw	Internal Fixation Systems, Inc.	2006	5
K161904	GEO Bone Screw System	Gramercy Extremity Orthopeidics, LLC	2017	4
K170038	FuzeFix Screw System	Fusion Orthopedics, LLC	2017	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?

Its one ancestor has no recall.
Of its descendants, K143460 (Wrightmedicaltechnologyinc, 2015) has gone furthest, with 11 descendants of its own.
9 other devices also cite its predicate K991151.

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 Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment.

These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042310: Ortho-Pro Cannulated Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042310

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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