510(k) · Cleared

Cleared

Isola (R) Tandem Connector

K922504510(k) TraditionalCleared May 18, 1993356-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 May 18, 1993 after a 356-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided: May 18, 1993
Review: 356 days
Class: Class II
Product code: KWP
Recalls: None
Predicates: 0

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

This deviceK922504 Isola (R) Tandem ConnectorAcromed Corp. · 1993
Descendant · cites it directly · 6 of its ownK141509 Isola and Expedium Growing Spine SystemsMedos Sarl · 2014
Descendant · 2 generations on · 3 of its ownK161028 K2M Growing Spine SystemK2m, Inc. · 2016
Descendant · 3 generations on · 2 of its ownK181068 CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018
Descendant · 2 generations on · 1 of its ownK142587 Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 2014 · Recalled
Descendant · 4 generations on · 0 of its ownK253739 SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization…Globus Medical, Inc. · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014high 2 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all

K141509Isola and Expedium Growing Spine SystemsMedos Sarl · 2014 · cites it directly6descendants
K161028K2M Growing Spine SystemK2m, Inc. · 2016 · 2 generations on3descendants
K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc. · 2018 · 3 generations on2descendants
K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc. · 2014 · 2 generations on1descendant
K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc. · 2026 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K922504	Isola (R) Tandem Connector	Acromed Corp.	1993	—
+1	K141509	Isola and Expedium Growing Spine Systems	Medos Sarl	2014	—
+2	K161028	K2M Growing Spine System	K2m, Inc.	2016	—
+3	K181068	CREO® Stabilization System, REVERE® Stabilization System	Globus Medical, Inc.	2018	—
+2	K142587	Vertical Expandable Prosthetic Titanium Rib	Depuy Synthes Spine, Inc.	2014	1
+4	K253739	SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System…	Globus Medical, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2016	1	0
2018	1	0
2019	1	0
2022	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K922504, 1993–2026Source: 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

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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? (8)

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

Number	Device	Applicant	Decided	Descendants
K141509	Isola and Expedium Growing Spine Systems	Medos Sarl	2014	6
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, K141509 (Medos Sarl, 2014) has gone furthest, with 6 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/K922504 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922504: Isola (R) Tandem Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922504

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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