510(k) · Cleared

Cleared

Asnis Micro Cannulated Screw

K071092510(k) SpecialCleared May 11, 200723-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 May 11, 2007 as substantially equivalent to K000080 (Howmedica Osteonics Corp., 2000) and 5 other predicates after a 23-day review. Its family tree reaches back 1 generation to 1996. 38 later devices descend from it.

Decided: May 11, 2007
Review: 23 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K962823 (1996). 6 ancestors in all. 38 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
This deviceK071092 Asnis Micro Cannulated ScrewHowmedica Osteonics Corp. · 2007
Descendant · cites it directly · 15 of its ownK080649 Pogo ScrewFxdevices · 2008
Descendant · 2 generations on · 12 of its ownK152686 Conquest FNSmith & Nephew · 2016
Descendant · cites it directly · 12 of its ownK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
Descendant · 3 generations on · 10 of its ownK193029 Conquest FNSmith & Nephew, Inc. · 2020
Descendant · 2 generations on · 8 of its ownK172785 Conquest FNSmith & Nephew · 2017

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2008high 6 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 38 · See all

K080649Pogo ScrewFxdevices · 2008 · cites it directly15descendants
K152686Conquest FNSmith & Nephew · 2016 · 2 generations on12descendants
K110658Aptus Cannulated Compression ScrewsMedartis AG · 2011 · cites it directly12descendants
K193029Conquest FNSmith & Nephew, Inc. · 2020 · 3 generations on10descendants
K172785Conquest FNSmith & Nephew · 2017 · 2 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962823	Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer	Synthes (Usa)	1996	—
0 (this device)	K071092	Asnis Micro Cannulated Screw	Howmedica Osteonics Corp.	2007	—
+1	K080649	Pogo Screw	Fxdevices	2008	—
+2	K152686	Conquest FN	Smith & Nephew	2016	—
+1	K110658	Aptus Cannulated Compression Screws	Medartis AG	2011	—
+3	K193029	Conquest FN	Smith & Nephew, Inc.	2020	—
+2	K172785	Conquest FN	Smith & Nephew	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2000	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	1	0
2011	1	0
2013	5	0
2015	2	0
2016	1	0
2017	2	0
2018	2	0
2020	2	0
2021	3	0
2022	4	0
2023	6	0
2024	1	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K071092, 1996–2026Source: 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? (6)

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
*	K000080	Asnis Iii Cannulated Screw System Our reading of the summary gave K000050, FDA’s number for Top Quality Chlorinated-Powderfree Examination Gloves (Top Quality Mfg., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Asnis III Cannulated Screw System”.	Howmedica Osteonics Corp.	2000	1
*	K024060	Modification to Asnis Iii Cannulated Screw System Summary page 1 …gn, intended use, performance and operational principle as internal fixation components. Predicate systems include the AsniSTM III Cannulated Screw System (KO0OOSO and K.024060) and other commercially available cannulated screws on the market such Vilex 2mmn Screws (K973309, K991 151 & K991 197) and Synth…	Howmedica Osteonics Corp.	2002	—
*	K973309	Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw Summary page 1 …e systems include the AsniSTM III Cannulated Screw System (KO0OOSO and K.024060) and other commercially available cannulated screws on the market such Vilex 2mmn Screws (K973309, K991 151 & K991 197) and Synthes Cannulated Screws (K962823.) Mechanical testing was conducted to compare the strength of the su…	Vilex, Inc.	1998	—
*	K991151	Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone Screw Summary page 1 …include the AsniSTM III Cannulated Screw System (KO0OOSO and K.024060) and other commercially available cannulated screws on the market such Vilex 2mmn Screws (K973309, K991 151 & K991 197) and Synthes Cannulated Screws (K962823.) Mechanical testing was conducted to compare the strength of the subject devi…	Vilex, Inc.	1999	—
*	K991197	Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX… Summary page 1 …e AsniSTM III Cannulated Screw System (KO0OOSO and K.024060) and other commercially available cannulated screws on the market such Vilex 2mmn Screws (K973309, K991 151 & K991 197) and Synthes Cannulated Screws (K962823.) Mechanical testing was conducted to compare the strength of the subject device to predi…	Vilex, Inc.	1999	—
*	K962823	Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer Summary page 1 …0OOSO and K.024060) and other commercially available cannulated screws on the market such Vilex 2mmn Screws (K973309, K991 151 & K991 197) and Synthes Cannulated Screws (K962823.) Mechanical testing was conducted to compare the strength of the subject device to predicate screws. The results demonstrate tha…	Synthes (Usa)	1996	—

Also cleared against K000080: 20 other devices →

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K080649	Pogo Screw	Fxdevices	2008	15
K110658	Aptus Cannulated Compression Screws	Medartis AG	2011	12
K082574	Maxtorque Mini Cannulated Screw System	Orthohelix Surgical Designs, Inc.	2008	3
K131324	Maxtorque Screw System	Orthohelix Surgical Designs, Inc.	2013	2
K132248	Flower Bone Screw Set	Flower Orthopedics Corporation	2013	1
K182810	Distal Radius Plating System	Miami Device Solutions, LLC	2018	0
K141401	Easy Out	Feet For Life Podiatry Center	2015	0
K130590	Aap Cannulated Screw 2.0	Aap Implantate AG	2013	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?

1 of the 6 ancestors has a recall of any class.
Of its descendants, K080649 (Fxdevices, 2008) has gone furthest, with 15 descendants of its own.
20 other devices also cite its predicate K000080.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071092 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071092: Asnis Micro Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071092

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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