510(k) Report

510(k) · Cleared

Cleared

Precice Intramedullary Limb Lengthening System

K133289510(k) SpecialCleared Dec 9, 201345-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 Dec 9, 2013 as substantially equivalent to K131677 (Ellipse Technologies, Inc., 2013) after a 45-day review. Its family tree reaches back 6 generations to 1983. 19 later devices descend from it.

Decided
Dec 9, 2013
Review
45 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K831576 (1983). 7 ancestors in all. 19 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2021: 1 descendant cleared2015: 2 descendants cleared2017: 2 descendants cleared2014: 2 descendants cleared2016: 1 descendant cleared2019: 1 descendant cleared2024: 2 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2020: 1 descendant cleared2025: 1 descendant clearedK831576 · Orthofix · Electro-Biology, Inc. · 1983K955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalledK010322 · Iskd (Intramedullary Skeletal Kinetic Distractor) · Orthodyne, Inc. · 2001 · recalledK031219 · Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) · Orthofix, Inc. · 2003 · recalledK101997 · Ellipse Intramedullary Limb Lengthening System · Ellipse Technologies, Inc. · 2011 · recalledK131677 · Precice Intramedullary Limb Lengthening System · Ellipse Technologies, Inc. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 4 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 7 descendants3 generations forward: 7 descendants K131677 · Precice Intramedullary Limb Lengthening System · Ellipse Technologies, Inc. · 2013K101997 · Ellipse Intramedullary Limb Lengthening System · Ellipse Technologies, Inc. · 2011 · recalledK031219 · Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) · Orthofix, Inc. · 2003 · recalledK010322 · Iskd (Intramedullary Skeletal Kinetic Distractor) · Orthodyne, Inc. · 2001 · recalledK955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalledK831576 · Orthofix · Electro-Biology, Inc. · 1983−50
  1. Root · 6 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
  2. 5 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
  3. 4 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
  4. 3 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
  5. 2 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
  6. 1 generation backK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
  7. This deviceK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
  8. Descendant · cites it directly · 9 of its ownK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
  9. Descendant · cites it directly · 9 of its ownK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
  10. Descendant · cites it directly · 6 of its ownK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
  11. Descendant · 2 generations on · 5 of its ownK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
  12. Descendant · 2 generations on · 3 of its ownK220234 Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2014: 22015: 22016: 12017: 22019: 12020: 12021: 12023: 32024: 22025: 12026: 3
2014high 3 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 19 · See all
  • K203399Fitbone (R) TaaWittenstein Intens GmbH · 2021 · cites it directly9descendants
  • K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014 · cites it directly9descendants
  • K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · cites it directly6descendants
  • K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016 · 2 generations on5descendants
  • K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K831576OrthofixElectro-Biology, Inc.1983—
−5K955848Orthofix ModulsystemOrthofix, Inc.199623
−4K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc.20011
−3K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc.20031
−2K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20112
−1K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2013—
0 (this device)K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2013—
+1K203399Fitbone (R) TaaWittenstein Intens GmbH2021—
+1K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2014—
+1K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated20152
+2K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2016—
+2K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201520
201610
201720
201910
202010
202110
202330
202420
202510
202630
FIG. 1 — Lineage of K133289, 1983–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K131677Precice Intramedullary Limb Lengthening System
Summary page 2
…None Based on the non-clinical testing performed, the 8.5 mm PRECICE Nail in this Special 5 10(k) is as safe, effective, and performs as well as the predicate device (K 131677). /DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Ellipse Technologies, Inc.2013—

Also cleared against K131677: 5 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K203399Fitbone (R) TaaWittenstein Intens GmbH20219
K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20149
K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated20156
K150656PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated20153
K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc.20172

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 30 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
  • 4 of the 7 ancestors have a recall of any class.
  • Of its descendants, K203399 (Wittenstein Intens GmbH, 2021) has gone furthest, with 9 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. 2013, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
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

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

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.

Also cleared against K131677

5 other devices cite the same predicate.

  • K203399Fitbone (R) TaaWittenstein Intens GmbH · 2021
  • K163368Fitbone TaaWittenstein Intens GmbH · 2017
  • K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 20152 recalls
  • K150656PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015
  • K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014

More from Ellipse Technologies, Inc.

13 FDA decisions under this applicant name. See the company

  • K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
  • K141278Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2015
  • K141739Residual Limb Lengthening SystemEllipse Technologies, Inc. · 20142 recalls
  • K140613Magec Spinal Bracing and Distraction SystemEllipse Technologies, Inc. · 2014
  • K141447Precice Trauma Nail SystemEllipse Technologies, Inc. · 2014

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K133289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133289: 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/K133289

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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