510(k) · Cleared

Cleared

University Plate Anterior System

K980228510(k) TraditionalCleared Apr 14, 199882-day reviewClass II21 CFR 888.3060

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

Acromed Corp. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Apr 14, 1998 as substantially equivalent to K904446 (Acromed Corp., 1991) and 2 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Apr 14, 1998
Review: 82 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K904446 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK904446 Casf (TM) (Contoured Anterior Spinal Fixaton Sys.)Acromed Corp. · 1991
This deviceK980228 University Plate Anterior SystemAcromed Corp. · 1998
Descendant · cites it directly · 0 of its ownK192281 AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System…Medos International SARL · 2019

Most influential descendants

Showing 1 of 1 · See all

K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K904446	Casf (TM) (Contoured Anterior Spinal Fixaton Sys.)	Acromed Corp.	1991	—
0 (this device)	K980228	University Plate Anterior System	Acromed Corp.	1998	—
+1	K192281	AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior…	Medos International SARL	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K980228, 1991–2019Source: 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 KWQ? 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 KWQ device

#1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K904446	Casf (TM) (Contoured Anterior Spinal Fixaton Sys.) Summary page 2 …eviously cleared components. The University*™ Plate™ Anterior System is substantially equivalent to the CASF™ Contoured Anterior Spinal Fixation System as cleared under K904446, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as clear…	Acromed Corp.	1991	—
*	K923703	Kaneda Anterior Spinal Multisegmental Fixation Dev Summary page 2 …ly equivalent to the CASF™ Contoured Anterior Spinal Fixation System as cleared under K904446, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as cleared under K943819. %, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public…	Acromed Corp.	1993	—
*	K943819	Isola Anterior System Summary page 2 …System as cleared under K904446, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as cleared under K943819. %, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 5 WEALTY &° ¢y, Food and Drug Administration…	Acromed Corp.	1995	—

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
K192281	AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…	Medos International SARL	2019	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 3 ancestors has a recall.
Of its descendants, K192281 (Medos International SARL, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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	27	101	2	288
2008	32	70	33	348
2009	23	90	35	355
2010	23	104	2	691
2011	22	95	5	415
2012	26	90	7	544
2013	22	88	6	796
2014	17	124	0	546
2015	25	102	2	562
2016	15	121	9	502
2017	20	67	8	492
2018	22	95	1	341
2019	26	81	0	298
2020	26	55	0	400
2021	17	59	0	591
2022	18	85	0	392
2023	16	59	0	320
2024	17	64	0	419
2025	7	64	0	248
2026	10	76	0	—

What is it indicated for?

The University™ Plate™ Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudoarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

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/K980228 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980228: University Plate Anterior System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980228

Report an extraction error

Are you the manufacturer?

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