510(k) · Cleared

Cleared

Inion Otps Biodegradable Mini Plating System

K043142510(k) TraditionalCleared Feb 18, 200595-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

Inion, Ltd. · HWC Screw, Fixation, Bone

Cleared on Feb 18, 2005 as substantially equivalent to K992301 (Biomet Manufacturing, Inc., 1999) and 1 other predicate after a 95-day review. Its family tree reaches back 1 generation to 1999. 19 later devices descend from it.

Decided: Feb 18, 2005
Review: 95 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K992301 (1999). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK992301 Reunite ScrewsBiomet Manufacturing, Inc. · 1999
This deviceK043142 Inion Otps Biodegradable Mini Plating SystemInion, Ltd. · 2005
Descendant · cites it directly · 17 of its ownK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
Descendant · 2 generations on · 8 of its ownK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
Descendant · 2 generations on · 6 of its ownK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
Descendant · 3 generations on · 4 of its ownK221193 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022
Descendant · 3 generations on · 4 of its ownK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2013high 3 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 19 · See all

K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY · 2013 · cites it directly17descendants
K160304OsteoBullet Compression ScrewPhalanx Innovations · 2016 · 2 generations on8descendants
K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020 · 2 generations on6descendants
K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022 · 3 generations on4descendants
K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992301	Reunite Screws	Biomet Manufacturing, Inc.	1999	—
0 (this device)	K043142	Inion Otps Biodegradable Mini Plating System	Inion, Ltd.	2005	—
+1	K123672	Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)	Inion OY	2013	—
+2	K160304	OsteoBullet Compression Screw	Phalanx Innovations	2016	—
+2	K193660	OSSIOfiber™ Compression Screws	OSSIO, Ltd.	2020	—
+3	K221193	OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm	OSSIO, Ltd.	2022	—
+3	K213596	OSSIOfiber Compression Screw, 3.5mm	OSSIO, Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0
2016	1	0
2018	1	0
2019	2	0
2020	3	0
2021	2	0
2022	2	0
2023	2	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K043142, 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 22.3 · 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? (2)

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
*	K992301	Reunite Screws Summary page 1 …I 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87-HWC (Screw) PREDICATE DEVICES Biomnet Inc.; ReUnite Bone Screw (K992301) Linvatec Smart Screw (K003077) Inion OTPS Screws extension Date: N…	Biomet Manufacturing, Inc.	1999	—
*	K003077	Smartscrew Model 222006...227510 Summary page 1 …hreaded metallic bone fixation fastener, 87-HWC (Screw) PREDICATE DEVICES Biomnet Inc.; ReUnite Bone Screw (K992301) Linvatec Smart Screw (K003077) Inion OTPS Screws extension Date: Nov 12,2004…	Bionx Implants, Ltd.	2001	—

Also cleared against K992301: 6 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K123672	Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)	Inion OY	2013	17
K151241	Synchro-Medical TIGER TRACK Screw System	Synchro Medical	2015	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?

None of the 2 ancestors has a recall.
Of its descendants, K123672 (Inion OY, 2013) has gone furthest, with 17 descendants of its own.
6 other devices also cite its predicate K992301.

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?

These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043142 · printed Nov 3, 2026

Cite this page

510(k) Report. “K043142: Inion Otps Biodegradable Mini Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043142

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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