510(k) · Cleared

Cleared

Precice Intramedullary Limb Lengthening System

K141023510(k) SpecialCleared May 20, 201429-day reviewClass II21 CFR 888.3020

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

Ellipse Technologies, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 20, 2014 as substantially equivalent to K131677 (Ellipse Technologies, Inc., 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 7 generations to 1983. 9 later devices descend from it.

Decided: May 20, 2014
Review: 29 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 2

Its longest line of descent runs back 7 generations to K831576 (1983). 8 ancestors in all. 9 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 7 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
6 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
5 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
4 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
3 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
2 generations backK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
1 generation backK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
This deviceK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
Descendant · cites it directly · 6 of its ownK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
Descendant · 2 generations on · 5 of its ownK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
Descendant · cites it directly · 3 of its ownK150656 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015
Descendant · cites it directly · 2 of its ownK170169 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
Descendant · 2 generations on · 1 of its ownK191336 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2019

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2014high 2 (2015) · low 0 (2018)2026

Most influential descendants

Showing 5 of 9 · See all

K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · cites it directly6descendants
K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016 · 2 generations on5descendants
K150656PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · cites it directly3descendants
K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017 · cites it directly2descendants
K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K831576	Orthofix	Electro-Biology, Inc.	1983	—
−6	K955848	Orthofix Modulsystem	Orthofix, Inc.	1996	23
−5	K010322	Iskd (Intramedullary Skeletal Kinetic Distractor)	Orthodyne, Inc.	2001	1
−4	K031219	Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)	Orthofix, Inc.	2003	1
−3	K101997	Ellipse Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	2011	2
−2	K131677	Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	2013	—
−1	K133289	Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	2013	—
0 (this device)	K141023	Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	2014	—
+1	K151131	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Incorporated	2015	2
+2	K160325	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	2016	—
+1	K150656	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Incorporated	2015	—
+1	K170169	PRECICE Intramedullary Limb Lengthening System	Nuvasive Specialized Orthopedics, Inc.	2017	—
+2	K191336	PRECICE System	Nuvasive Specialized Orthopedics, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	2	0
2016	1	0
2017	2	0
2019	1	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K141023, 1983–2026Source: 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 HSB? 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 HSB device

#1 K200869 Gamma3 Systemscore 19.8 · 8 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? (2)

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
*	K131677	Precice Intramedullary Limb Lengthening System Summary page 1 …to the predicate devices demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device: *Ellipse PRECICE System (K13 1677 and K 133289) Substantial equivalence is based on similar indications for use, designs. and on in vitro testing performed. The Ri…	Ellipse Technologies, Inc.	2013	—
*	K133289	Precice Intramedullary Limb Lengthening System Summary page 1 …cate devices demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device: *Ellipse PRECICE System (K13 1677 and K 133289) Substantial equivalence is based on similar indications for use, designs. and on in vitro testing performed. The Risk Management…	Ellipse Technologies, Inc.	2013	—

Also cleared against K131677: 5 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K151131	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Incorporated	2015	6
K150656	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Incorporated	2015	3
K170169	PRECICE Intramedullary Limb Lengthening System	Nuvasive Specialized Orthopedics, Inc.	2017	2
K141739	Residual Limb Lengthening System	Ellipse Technologies, Inc.	2014	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?

The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
4 of the 8 ancestors have a recall of any class.
Of its descendants, K151131 (Ellipse Technologies, Incorporated, 2015) has gone furthest, with 6 descendants of its own.
5 other devices also cite its predicate K131677.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

What is it indicated for?

The Ellipse PRECICE System is indicated for limb lengthening of the tibia and femur.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141023 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141023: Precice Intramedullary Limb Lengthening System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141023

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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