510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Iskd (Intramedullary Skeletal Kinetic Distractor)

K010322510(k) TraditionalCleared May 2, 200189-day reviewClass II21 CFR 888.3020Recalls 1

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

Orthodyne, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on May 2, 2001 as substantially equivalent to K983358 (Howmedica, Inc., 1998) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1983. 35 later devices descend from it. It has been recalled once.

Decided
May 2, 2001
Review
89 days
Class
Class II
Product code
HSB
Recalls
1
Predicates
2

Its longest line of descent runs back 2 generations to K831576 (1983). 3 ancestors in all. 35 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2003: 2 descendants cleared2017: 4 descendants cleared2011: 1 descendant cleared2019: 2 descendants cleared2005: 1 descendant cleared2012: 2 descendants cleared2013: 2 descendants cleared2014: 4 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2015: 4 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2025: 1 descendant clearedK831576 · Orthofix · Electro-Biology, Inc. · 1983K955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 10 descendants4 generations forward: 7 descendants5 generations forward: 7 descendants K955848 · Orthofix Modulsystem · Orthofix, Inc. · 1996 · recalledK831576 · Orthofix · Electro-Biology, Inc. · 19830+5
  1. Root · 2 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
  2. 1 generation backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
  3. This deviceK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001
  4. Descendant · cites it directly · 30 of its ownK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
  5. Descendant · cites it directly · 29 of its ownK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
  6. Descendant · 2 generations on · 21 of its ownK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
  7. Descendant · 3 generations on · 19 of its ownK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
  8. Descendant · 2 generations on · 15 of its ownK113219 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2003: 22005: 12011: 12012: 22013: 22014: 42015: 42016: 12017: 42019: 22020: 22021: 12023: 32024: 22025: 12026: 3
2003high 4 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 35 · See all
  • K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · cites it directly30descendants
  • K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · cites it directly29descendants
  • K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013 · 2 generations on21descendants
  • K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013 · 3 generations on19descendants
  • K113219Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K831576OrthofixElectro-Biology, Inc.1983—
−1K955848Orthofix ModulsystemOrthofix, Inc.199623
0 (this device)K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc.2001—
+1K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc.20031
+1K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20112
+2K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2013—
+3K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2013—
+2K113219Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
201110
201220
201320
201440
201540
201610
201740
201920
202020
202110
202330
202420
202510
202630
FIG. 1 — Lineage of K010322, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K983358G/K SFN and STN Locking Nails
Summary page 1
…y Howmedica Corp. of Rutherford, New Jersey. The Gross Kempf (i.e., GK Nail) device was originally cleared by FDA under K813371 on March 1, 1982, and most recently under K983358 on November 18, 1998. The Orthodyne ISKD System is substantially equivalent in intended use to the Orthofix Dynamic Axial Fixatio…
Howmedica, Inc.1998—
*K955848Orthofix Modulsystem
Summary page 1
…358 on November 18, 1998. The Orthodyne ISKD System is substantially equivalent in intended use to the Orthofix Dynamic Axial Fixation System cleared by FDA under 510(k) K955848 on March 20, 1996 -Orthodyne Inc. Premarket Notification: ISKD Internal Limb Lengthening System Submitted: January 22, 2001 ==…
Orthofix, Inc.199623

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc.200330
K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.201129
K031875Inter-OS Limb LengthenerInter-Os Technologies20034
K163653NOVOS-NAIL Limb Lengthening System (LLS)Smith & Nephew20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 6, 2012Class IIZ-0895-2013Nonconforming Material/ComponentThere is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation (limb not achieving the desired length) leading to revision surgery to remove…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K031219 (Orthofix, Inc., 2003) has gone furthest, with 30 descendants of its own.

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.

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 ISKD is indicated for limb lengthening of the tibia and femur.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K010322 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010322: Iskd (Intramedullary Skeletal Kinetic Distractor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010322

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026