510(k) · Cleared

Cleared

Isola Slotted Connect/Angled Slotted Connector

K905826510(k) TraditionalCleared Mar 21, 199180-day reviewClass II21 CFR 888.3050

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

Acromed Corp. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Mar 21, 1991 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 69 later devices descend from it.

Decided: Mar 21, 1991
Review: 80 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 0

69 later devices descend from it, 2 citing it directly.

This deviceK905826 Isola Slotted Connect/Angled Slotted ConnectorAcromed Corp. · 1991
Descendant · cites it directly · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
Descendant · 2 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
Descendant · 3 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
Descendant · 4 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
Descendant · 2 generations on · 19 of its ownK150896 Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · Recalled

Showing 5 of 69 descendants. See all descendants

Descendants cleared per year

2014high 10 (2024) · low 1 (2016)2026

Most influential descendants

Showing 5 of 69 · See all

K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · cites it directly67descendants
K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 2 generations on30descendants
K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 3 generations on26descendants
K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 4 generations on21descendants
K150896Vitality Spinal Fixation SystemZimmer Spine, Inc. · 2015 · 2 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K905826	Isola Slotted Connect/Angled Slotted Connector	Acromed Corp.	1991	—
+1	K133746	Polaris Spinal System	Biomet Spine (Aka Ebi, LLC)	2014	1
+2	K143248	Reform Pedicle Screw System	Precision Spine, Inc.	2014	—
+3	K150856	Reform Pedicle Screw System	Precision Spine, Inc.	2015	—
+4	K173130	Reform® Midline Cortical Screw System	Precision Spine, Inc.	2017	—
+2	K150896	Vitality Spinal Fixation System	Zimmer Spine, Inc.	2015	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2015	4	0
2016	1	0
2017	5	0
2018	2	0
2019	4	0
2020	5	0
2021	6	0
2022	6	0
2023	8	0
2024	10	0
2025	8	0
2026	8	0

FIG. 1 — Lineage of K905826, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (69)

See all 69

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

Number	Device	Applicant	Decided	Descendants
K133746	Polaris Spinal System	Biomet Spine (Aka Ebi, LLC)	2014	67
K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…	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?

Of its descendants, K133746 (Biomet Spine (Aka Ebi, LLC), 2014) has gone furthest, with 67 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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	14	96	2	210
2008	13	50	1	594
2009	12	89	23	682
2010	14	186	2	474
2011	12	67	6	792
2012	18	112	1	918
2013	12	99	3	1,090
2014	13	138	0	1,022
2015	9	113	1	1,348
2016	0	—	3	1,379
2017	0	—	0	864
2018	0	—	1	657
2019	0	—	2	518
2020	0	—	0	796
2021	0	—	0	525
2022	0	—	2	335
2023	0	—	0	332
2024	0	—	0	436
2025	0	—	0	494
2026	0	—	0	—

https://510kreport.com/device/K905826 · printed Nov 4, 2026

Cite this page

510(k) Report. “K905826: Isola Slotted Connect/Angled Slotted Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K905826

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026