510(k) · Cleared

Cleared

Kaneda SR Anterior Spinal System

K971248510(k) TraditionalCleared Jun 11, 199769-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 Jun 11, 1997 as substantially equivalent to K873826 (Acromed Corp., 1988) and 2 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1988. 82 later devices descend from it.

Decided: Jun 11, 1997
Review: 69 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K873826 (1988). 3 ancestors in all. 82 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK873826 Acromed/Kaneda Anterior Spinal InstrumentationAcromed Corp. · 1988
This deviceK971248 Kaneda SR Anterior Spinal SystemAcromed Corp. · 1997
Descendant · cites it directly · 73 of its ownK100061 Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010
Descendant · 2 generations on · 72 of its ownK131533 Cayman MI Plate SystemK2m, Inc. · 2013
Descendant · 3 generations on · 52 of its ownK172941 CASCADIA Interbody SystemK2m · 2018
Descendant · 4 generations on · 24 of its ownK181347 Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018
Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019

Showing 5 of 82 descendants. See all descendants

Descendants cleared per year

2004high 14 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 82 · See all

K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc. · 2010 · cites it directly73descendants
K131533Cayman MI Plate SystemK2m, Inc. · 2013 · 2 generations on72descendants
K172941CASCADIA Interbody SystemK2m · 2018 · 3 generations on52descendants
K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC · 2018 · 4 generations on24descendants
K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K873826	Acromed/Kaneda Anterior Spinal Instrumentation	Acromed Corp.	1988	—
0 (this device)	K971248	Kaneda SR Anterior Spinal System	Acromed Corp.	1997	—
+1	K100061	Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX	K2m, Inc.	2010	—
+2	K131533	Cayman MI Plate System	K2m, Inc.	2013	—
+3	K172941	CASCADIA Interbody System	K2m	2018	—
+4	K181347	Aries® Lumbar Interbodies	Osseus Fusion Systems, LLC	2018	—
+3	K190016	Lateral Plate System	Corelink, LLC	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
2004	1	0
2008	1	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2015	1	0
2016	1	0
2018	3	0
2019	6	0
2020	3	0
2021	4	0
2022	8	0
2023	14	0
2024	11	0
2025	13	0
2026	12	0

FIG. 1 — Lineage of K971248, 1988–2026Source: 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 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

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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
*	K873826	Acromed/Kaneda Anterior Spinal Instrumentation Summary page 2 …ntly with previously cleared components. The Kaneda SR Anterior Spinal System is substantially equivalent to the Kaneda Anterior Spinal Instrumentation as cleared under K873826, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as clear…	Acromed Corp.	1988	—
*	K923703	Kaneda Anterior Spinal Multisegmental Fixation Dev Summary page 2 …bstantially equivalent to the Kaneda Anterior Spinal Instrumentation as cleared under K873826, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as cleared under K943819. WEALTY , < <Ot 4, & ERVIC, . 5, 4, C DEPARTMEN…	Acromed Corp.	1993	—
*	K943819	Isola Anterior System Summary page 2 …tation as cleared under K873826, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as cleared under K943819. WEALTY , < <Ot 4, & ERVIC, . 5, 4, C DEPARTMENT GF HEALTH & HUMAN SERVICES Public Health Service (7 %, :'h…	Acromed Corp.	1995	—

Also cleared against K873826: 1 other device →

What descends from it? (82)

See all 82

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

Number	Device	Applicant	Decided	Descendants
K100061	Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX	K2m, Inc.	2010	73
K120074	Foundation Spinal System	The Skeletal Design Partnership, Ltd.	2012	2
K192281	AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…	Medos International SARL	2019	0
K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…	Medos International SARL	2019	0
K101353	Golden Gate Anterior Plate System	Ulrich GmbH & Co. KG	2011	0
K071074	Mykres Spinal System	Showa Ika Kohgyo Co., Ltd.	2008	0
K033148	Art Anterior Spinal System	Advanced Medical Technologies AG	2004	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, K100061 (K2m, Inc., 2010) has gone furthest, with 73 descendants of its own.
1 other device also cites its predicate K873826.

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 Kaneda SR Anterior Spinal System is intended for anterolateral screw fixation to the T10-L3 levels of the spine, with all metal at least 1.cm. froma major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The Kaneda system is used in conjunction with the Isola Spine System. Specifically, the 1) Isola %4 Rods 2) Isola Open Caps and 3) the Isola Set Screws are interchangeable parts.

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/K971248 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971248: Kaneda SR Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971248

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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