510(k) · Cleared

Cleared

Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

K212792510(k) TraditionalCleared Sep 23, 202122-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medynus, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Sep 23, 2021 as substantially equivalent to K162220 (Dio Medical Co., Ltd., 2016) after a 22-day review. Its family tree reaches back 1 generation to 2016.

Decided: Sep 23, 2021
Review: 22 days
Class: Class II
Product code: ODP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K162220 (2016). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK162220 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. · 2016
This deviceK212792 Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageMedynus, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K162220	DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage	Dio Medical Co., Ltd.	2016	—
0 (this device)	K212792	Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage	Medynus, Inc.	2021	—

FIG. 1 — Lineage of K212792, 2016–2021Source: 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 ODP? 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 ODP device

#1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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
*	K162220	DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage Summary page 4 …ce, Lumbar (Product Code MAX) Regulation Number: 21 C.F.R. §888.3080 IV. Predicate Devices: DIO Medical IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K162220) K212792…	Dio Medical Co., Ltd.	2016	—

Also cleared against K162220: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
3 other devices also cite its predicate K162220.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, 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	0	—	0	0
2008	8	89	0	2
2009	12	127	1	21
2010	9	151	0	54
2011	25	113	1	38
2012	17	93	0	92
2013	18	187	1	78
2014	26	118	0	43
2015	24	180	0	51
2016	17	112	0	37
2017	33	104	0	39
2018	25	133	0	51
2019	22	92	0	141
2020	14	89	1	86
2021	18	121	0	161
2022	12	92	0	50
2023	34	165	0	36
2024	10	76	0	55
2025	11	87	2	57
2026	19	117	0	—

What is it indicated for?

The Medynus IV A (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to…

Read the full statement (193 words)

The Medynus IV A (ACIF) PEEK Cage is indicated for intervertebral body fusion in skeletally mature patients with

degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the

C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and

radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate

fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral

cage.

The Medynus IVA (PLIF, TLIF, DLIF and ALIF) PEEK Cage is indicated for intervertebral body fusion of the lumbar

spine, from L2 to S 1, in skeletally mature patients who have had six months of non-operative treatment. The device is

intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to

Grade | spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by

history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to

facilitate fusion.

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/K212792 · printed Nov 6, 2026

Cite this page

510(k) Report. “K212792: Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212792

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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