510(k) · Cleared

Recalled · 2010

Inion CPS Bsso Screw

K020266510(k) SpecialCleared Feb 22, 200228-day reviewClass II21 CFR 888.3040Recalls 3

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 22, 2002 as substantially equivalent to K010352 (Inion, Ltd., 2001) after a 28-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled 3 times.

Decided: Feb 22, 2002
Review: 28 days
Class: Class II
Product code: HWC
Recalls: 3
Predicates: 1

Its longest line of descent runs back 1 generation to K010352 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010352 CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion, Ltd. · 2001 · Recalled
This deviceK020266 Inion CPS Bsso ScrewInion, Ltd. · 2002
Descendant · cites it directly · 0 of its ownK251441 Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS…Inion OY · 2025

Most influential descendants

Showing 1 of 1 · See all

K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…Inion OY · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010352	CPS 1.5/2.0/2.5 Bioabsorbable Fixation System	Inion, Ltd.	2001	3
0 (this device)	K020266	Inion CPS Bsso Screw	Inion, Ltd.	2002	—
+1	K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5…	Inion OY	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K020266, 2001–2025Source: 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
*	K010352	CPS 1.5/2.0/2.5 Bioabsorbable Fixation System Summary page 1 …CFR 888.3040 screws are classified as Class II. Screws have been assigned Product Code HWC. PREDICATE DEVICE (1) Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352) Special 510(k) 23.1.2002 Final i D/L K 0 0alofr a 8 INTENDED USE The Inion CPS" BSSO Screw is intended for u…	Inion, Ltd.	2001	3

Also cleared against K010352: 8 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K251441	Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable…	Inion OY	2025	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 14, 2010	Not classified	Z-0630-2011	Other	Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
Apr 14, 2010	Not classified	Z-0631-2011	Other	Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
Mar 5, 2010	Not classified	Z-1550-2010	Nonconforming Material/Component	During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K251441 (Inion OY, 2025) has gone furthest, with 0 descendants of its own.
8 other devices also cite its predicate K010352.

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?

Indications:

A. General indications: The Inion CPS™ BSSO Screw is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.

B. Specific indications:

Fractures of the cranium, midface, maxilla and mandible.

Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations).

LeFort (I, II, III) osteotomies.

Pediatric reconstructive procedures.

Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible.

Craniotomy flap fixation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020266: Inion CPS Bsso Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020266

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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