510(k) · Cleared
ClearedInter-OS Limb Lengthener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Os Technologies · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 22, 2003 as substantially equivalent to K993869 (Inter-Os Technologies, LLC, 2000) and 7 other predicates after a 127-day review. Its family tree reaches back 4 generations to 1999. 4 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 127 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 4 generations to K993886 (1999). 15 ancestors in all, the oldest K831576 (1983). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
- 3 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
- 2 generations backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
- 1 generation backK021031 Ebi Xfix Rail SystemEbi, L.P. · 2002
- This deviceK031875 Inter-OS Limb LengthenerInter-Os Technologies · 2003
- Descendant · cites it directly · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK193617 Precice® ScrewsNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK051162 Generos SB Small Bone Distraction ImplantOrthonetx, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · cites it directly2descendants
- K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020 · 2 generations on0descendants
- K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc. · 2020 · 2 generations on0descendants
- K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993886 | Ebi Xfix Vision Fixation System | Ebi, L.P. | 1999 | — |
| −3 | K011711 | Modification to Ebi Efix Vision Fixation System | Ebi, L.P. | 2001 | — |
| −2 | K014194 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2002 | — |
| −1 | K021031 | Ebi Xfix Rail System | Ebi, L.P. | 2002 | — |
| 0 (this device) | K031875 | Inter-OS Limb Lengthener | Inter-Os Technologies | 2003 | — |
| +1 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +2 | K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +2 | K193617 | Precice® Screws | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +1 | K051162 | Generos SB Small Bone Distraction Implant | Orthonetx, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 | Decided |
|---|---|---|---|
| * | K993869 | Inter-OS Bone GeneratorSummary page 2…also be used to fix the gear in position during the consolidation period. Predicate Devices The Inter-Os Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#IC982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and KO2103 l), the… | 2000 |
| * | K982222 | Synthes (Usa) Distal Femur Plate (DFP) SystemSummary page 2…ion during the consolidation period. Predicate Devices The Inter-Os Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#IC982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and KO2103 l), the OrthofidOrthodyne ISKD (#KO10322) and… | 1998 |
| * | K020872 | Synthes 3.5 MM Broad LC-DCP PlatesSummary page 2…the consolidation period. Predicate Devices The Inter-Os Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#IC982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and KO2103 l), the OrthofidOrthodyne ISKD (#KO10322) and others. We… | 2002 |
| * | K991941 | Ebi Xfix DFS Rail SystemSummary page 2…ces The Inter-Os Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#IC982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and KO2103 l), the OrthofidOrthodyne ISKD (#KO10322) and others. We believe the Inter-Os device to be substant… | 1999 |
| * | K000083 | Ebi Xfix DFS Rail SystemSummary page 2…Inter-Os Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#IC982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and KO2103 l), the OrthofidOrthodyne ISKD (#KO10322) and others. We believe the Inter-Os device to be substantially equ… | 2000 |
| * | K010437 | Modification to Ebi Xfix DFS Rail SystemSummary page 2…Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#IC982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and KO2103 l), the OrthofidOrthodyne ISKD (#KO10322) and others. We believe the Inter-Os device to be substantially equivalent b… | 2001 |
| * | K021031 | Ebi Xfix Rail System | 2002 |
| * | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | 2001 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K192181 (Nuvasive Specialized Orthopedics, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K993869.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Inter-Os Limb Lengthener is an implantable device for distraction osteogenesis techniques in the femur. The Inter-Os Limb Lengthener is used to treat conditions for limb length deficiencies involving the femur. The types of deformities that fall into this category are: Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities. The Inter-Os Limb Lengthener is intended to be used in the upper…
Read the full statement (188 words)
The Inter-Os Limb Lengthener is an implantable device for distraction osteogenesis techniques in the femur. The Inter-Os Limb Lengthener is used to treat conditions for limb length deficiencies involving the femur. The types of deformities that fall into this category are:
Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities.
The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine
The Inter-Os Limb Lengthener is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after consolidation of the bone is complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. Bone cement is not to be used to fixate the device to the bone; however, commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface, or bone cement may also be used to fix the gear in position during the consolidation period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031875: Inter-OS Limb Lengthener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031875
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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