510(k) · Cleared
ClearedGeneros SB Small Bone Distraction Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthonetx, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jul 19, 2005 as substantially equivalent to K993869 (Inter-Os Technologies, LLC, 2000) and 4 other predicates after a 75-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Jul 19, 2005
- Review
- 75 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K993886 (1999). 31 ancestors in all, the oldest K831576 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
- 4 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
- 3 generations backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
- 2 generations backK021031 Ebi Xfix Rail SystemEbi, L.P. · 2002
- 1 generation backK031875 Inter-OS Limb LengthenerInter-Os Technologies · 2003
- This deviceK051162 Generos SB Small Bone Distraction ImplantOrthonetx, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993886 | Ebi Xfix Vision Fixation System | Ebi, L.P. | 1999 | — |
| −4 | K011711 | Modification to Ebi Efix Vision Fixation System | Ebi, L.P. | 2001 | — |
| −3 | K014194 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2002 | — |
| −2 | K021031 | Ebi Xfix Rail System | Ebi, L.P. | 2002 | — |
| −1 | K031875 | Inter-OS Limb Lengthener | Inter-Os Technologies | 2003 | — |
| 0 (this device) | 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 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 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? (5)
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…surface of the device to level or stabilize it on a curved surface. PREDICATE DEVICES * GenerOs Bone Generator; OrthoNetx, Inc. (formerly Inter-Os Technologies) (#K993869) · Limb Lengthener; OrthoNetx, Inc, (#K031875) · Arthrex Small Fragment Plates and Screws; Arthrex, Inc., (#K040907) * Lore… | 2000 |
| * | K031875 | Inter-OS Limb LengthenerSummary page 2…n a curved surface. PREDICATE DEVICES * GenerOs Bone Generator; OrthoNetx, Inc. (formerly Inter-Os Technologies) (#K993869) · Limb Lengthener; OrthoNetx, Inc, (#K031875) · Arthrex Small Fragment Plates and Screws; Arthrex, Inc., (#K040907) * Lorenz Small Fragment System (#K992961); Walter Lore… | 2003 |
| * | K040907 | Arthrex Small Fragment Plates and ScrewsSummary page 2…Netx, Inc. (formerly Inter-Os Technologies) (#K993869) · Limb Lengthener; OrthoNetx, Inc, (#K031875) · Arthrex Small Fragment Plates and Screws; Arthrex, Inc., (#K040907) * Lorenz Small Fragment System (#K992961); Walter Lorenz Surgical, Inc. * LCP Modular Foot Plates; Synthes (USA), (#K050110)… | 2004 |
| * | K992961 | Lorenz Small Fragment SystemSummary page 2…(#K993869) · Limb Lengthener; OrthoNetx, Inc, (#K031875) · Arthrex Small Fragment Plates and Screws; Arthrex, Inc., (#K040907) * Lorenz Small Fragment System (#K992961); Walter Lorenz Surgical, Inc. * LCP Modular Foot Plates; Synthes (USA), (#K050110) Confidential… | 1999 |
| * | K050110 | Synthes (Usa) LCP Modular Foot PlatesSummary page 2…ment Plates and Screws; Arthrex, Inc., (#K040907) * Lorenz Small Fragment System (#K992961); Walter Lorenz Surgical, Inc. * LCP Modular Foot Plates; Synthes (USA), (#K050110) Confidential 1-4… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 31 ancestors have a recall of any class.
- 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 GenerOs SB is an implantable device for distraction osteogenesis techniques in the small bone of the extremities. GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to: * Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet; * Post-traumatic deficiencies of the bones of the forearms, wrists…
Read the full statement (175 words)
The GenerOs SB is an implantable device for distraction osteogenesis techniques in the small bone of the extremities. GenerOs SB is used to treat conditions where small bones of the extremities are deficient. The types of deformities that fall into this category include, but are not limited to:
* Congenital deficiencies of the bones of the forearms, wrists, ankles, hands and feet;
* Post-traumatic deficiencies of the bones of the forearms, wrists, ankles, hands and feet;
* Deficiencies of the bones of the forearms, wrists, ankles, hands and feet due to tumor resection.
Each GenerOs SB is intended for single use only. The device is to be removed after distraction and bone stabilization are complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. The device is not intended to be fixed to the bone with bone cement. However, it is possible that commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051162: Generos SB Small Bone Distraction Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051162
Report an extraction error
Are you the manufacturer?
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