510(k) · Cleared

Cleared

Propeller Head Small Cannulated Screw System

K024086510(k) SpecialCleared Jan 9, 200329-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

Biomet Orthopedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Jan 9, 2003 as substantially equivalent to K013534 (Biomet Orthopedics, Inc., 2001) after a 29-day review. Its family tree reaches back 2 generations to 1992. 171 later devices descend from it.

Decided: Jan 9, 2003
Review: 29 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K922322 (1992). 5 ancestors in all. 171 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
1 generation backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
This deviceK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
Descendant · cites it directly · 168 of its ownK082874 Biodrive Cannulated Screw SystemBiomet Trauma · 2009
Descendant · 2 generations on · 143 of its ownK093629 Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · Recalled
Descendant · 3 generations on · 142 of its ownK113796 Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · Recalled
Descendant · 4 generations on · 108 of its ownK132029 Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013
Descendant · 5 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019

Showing 5 of 171 descendants. See all descendants

Descendants cleared per year

2009high 26 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 171 · See all

K082874Biodrive Cannulated Screw SystemBiomet Trauma · 2009 · cites it directly168descendants
K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine · 2010 · 2 generations on143descendants
K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 2012 · 3 generations on142descendants
K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA · 2013 · 4 generations on108descendants
K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 5 generations on93descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K922322	Alphatec 3.5MM Znnulated Cortical Lag Screw	Alphatec Mfg., Inc.	1992	—
−1	K013534	Self-Countersinking Bone Screw	Biomet Orthopedics, Inc.	2001	—
0 (this device)	K024086	Propeller Head Small Cannulated Screw System	Biomet Orthopedics, Inc.	2003	—
+1	K082874	Biodrive Cannulated Screw System	Biomet Trauma	2009	—
+2	K093629	Solitaire and Solitaire Peek Anterior Spinal System	Biomet Spine	2010	1
+3	K113796	Solitaire-C Cervical Spacer System	Ebi, LLC	2012	1
+4	K132029	Vault-C Intervertebral Body Fusion Device	Spinal USA	2013	—
+5	K190546	NEXXT MATRIXX Stand Alone Cervical System	Nexxt Spine, LLC	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2010	1	0
2012	1	0
2013	2	0
2014	3	0
2015	2	0
2016	3	0
2017	6	0
2018	3	0
2019	3	0
2020	9	0
2021	15	0
2022	25	0
2023	24	0
2024	23	0
2025	26	0
2026	23	0

FIG. 1 — Lineage of K024086, 1992–2026Source: 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
*	K013534	Self-Countersinking Bone Screw Summary page 1 …ne (888.3040) Device Product Code: 87HWC Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Self-Countersinking Bone Screw (K013534) Indications for Use: The Propeller Head Small Cannulated Screw System is indicated for the following conditions: 0 Fi…	Biomet Orthopedics, Inc.	2001	—

Also cleared against K013534: 2 other devices →

What descends from it? (171)

See all 171

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

Number	Device	Applicant	Decided	Descendants
K082874	Biodrive Cannulated Screw System	Biomet Trauma	2009	168
K081813	Universal Compression Fracture Repair System	U.S. Implant Solutions, LLC	2009	4

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 11 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K082874 (Biomet Trauma, 2009) has gone furthest, with 168 descendants of its own.
2 other devices also cite its predicate K013534.

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 Propeller Head Small Cannulated Screw System is indicated for the following conditions:

Fixation of fractures in long bones.

Fixation of the small bones, including those in the foot, patella, ankle, wrist and elbow.

Ligament reconstruction

Arthrodesis of the foot, ankle, wrist and elbow.

Small bone osteotomies

Osteochondritis dissecans

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024086 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024086: Propeller Head Small 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/K024086

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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