510(k) · Cleared

Cleared

Orthofix

K831576510(k) TraditionalCleared Jun 8, 198323-day reviewClass II21 CFR 888.3040

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

Electro-Biology, Inc. · JEC Component, Traction, Invasive

Cleared on Jun 8, 1983 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 103 later devices descend from it.

Decided: Jun 8, 1983
Review: 23 days
Class: Class II
Product code: JEC
Recalls: None
Predicates: 0

103 later devices descend from it, 6 citing it directly.

This deviceK831576 OrthofixElectro-Biology, Inc. · 1983
Descendant · cites it directly · 95 of its ownK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
Descendant · 2 generations on · 35 of its ownK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
Descendant · 2 generations on · 32 of its ownK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
Descendant · 3 generations on · 30 of its ownK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
Descendant · 3 generations on · 29 of its ownK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

1996high 10 (2014) · low 0 (1997)2026

Most influential descendants

Showing 5 of 103 · See all

K955848Orthofix ModulsystemOrthofix, Inc. · 1996 · cites it directly95descendants
K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · 2 generations on35descendants
K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014 · 2 generations on32descendants
K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · 3 generations on30descendants
K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · 3 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K831576	Orthofix	Electro-Biology, Inc.	1983	—
+1	K955848	Orthofix Modulsystem	Orthofix, Inc.	1996	23
+2	K010322	Iskd (Intramedullary Skeletal Kinetic Distractor)	Orthodyne, Inc.	2001	1
+2	K141078	Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)	Orthofix Srl	2014	—
+3	K031219	Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)	Orthofix, Inc.	2003	1
+3	K101997	Ellipse Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	2011	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
2001	1	0
2003	4	0
2005	4	0
2006	1	0
2007	2	0
2010	3	0
2011	2	0
2012	4	0
2013	3	0
2014	10	0
2015	6	0
2016	3	0
2017	8	0
2018	4	0
2019	5	0
2020	8	0
2021	5	0
2022	1	0
2023	5	0
2024	5	0
2025	8	0
2026	8	0

FIG. 1 — Lineage of K831576, 1983–2026Source: 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 JEC? 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 JEC device

#1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
#2 Held for the reportin 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? (103)

See all 103

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

Number	Device	Applicant	Decided	Descendants
K955848	Orthofix Modulsystem	Orthofix, Inc.	1996	95
K974911	External Fixator	Avanta Orthopaedics, Inc.	1998	3
K032427	Fep Fixation System and Stylo Wrist Fixation System	Meridan Medical	2003	2
K981716	External Fixation	Avanta Orthopaedics, Inc.	1998	2
K023714	Reprocessed External Fixation Device	Alliance Medical Corp.	2003	1
K101338	Newfix External Fixation System	Technologia Y Diseno Industrial, S.A DE C.V	2011	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, K955848 (Orthofix, Inc., 1996) has gone furthest, with 95 descendants of its own.

How does its category compare?

All JEC devices

JEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEC

1in 2021

2007high 2 (2018) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEC

Too few JEC 510(k)s in any year since 2007 to give a median.

Recalls per year · JEC

1in 2019

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JEC

2in 2025

2007high 26 (2023) · low 1 (2007)2025

MAUDE reports naming product code JEC, 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	1	—	0	1
2008	1	—	1	9
2009	1	—	0	4
2010	0	—	0	13
2011	1	—	0	15
2012	0	—	0	14
2013	0	—	0	10
2014	1	—	0	6
2015	0	—	0	1
2016	1	—	1	8
2017	0	—	0	12
2018	2	—	1	2
2019	1	—	1	3
2020	1	—	0	6
2021	1	—	0	2
2022	0	—	0	3
2023	0	—	0	26
2024	0	—	0	2
2025	0	—	0	2
2026	0	—	0	—

https://510kreport.com/device/K831576 · printed Nov 4, 2026

Cite this page

510(k) Report. “K831576: Orthofix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831576

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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