510(k) · Cleared
ClearedInter-OS Bone Generator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Os Technologies, LLC · MQN External Mandibular Fixator And/Or Distractor
Cleared on Jan 19, 2000 after a 65-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Jan 19, 2000
- Review
- 65 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK993869 Inter-OS Bone GeneratorInter-Os Technologies, LLC · 2000
- Descendant · cites it directly · 4 of its ownK031875 Inter-OS Limb LengthenerInter-Os Technologies · 2003
- Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · 3 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 5 of 5 · See all- K031875Inter-OS Limb LengthenerInter-Os Technologies · 2003 · cites it directly4descendants
- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
- K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on0descendants
- K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc. · 2020 · 3 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 |
|---|---|---|---|---|---|
| 0 (this device) | K993869 | Inter-OS Bone Generator | Inter-Os Technologies, LLC | 2000 | — |
| +1 | K031875 | Inter-OS Limb Lengthener | Inter-Os Technologies | 2003 | — |
| +2 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +3 | K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +3 | K193617 | Precice® Screws | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +1 | K051162 | Generos SB Small Bone Distraction Implant | Orthonetx, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 MQN? 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 MQN device
- #1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Howmedica Leibinger MID System Named without a submission number | |
| * | — | Synthes Mandibular Distractor Named without a submission number | |
| * | — | KLS Martin Mandibular Distractor Named without a submission number | |
| * | — | Howmedica Mandibular Distractor Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K031875 (Inter-Os Technologies, 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MQN devicesMQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 2025
MAUDE reports naming product code MQN, 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 | 4 | 77 | 0 | 5 |
| 2008 | 3 | 292 | 0 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 1 | — | 0 | 107 |
| 2013 | 0 | — | 0 | 179 |
| 2014 | 1 | — | 1 | 57 |
| 2015 | 1 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 87 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 108 |
| 2019 | 1 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 101 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The inter-Os Bone Generator™ is an implantable device for distraction osteogenesis techniques in the facial bones implanted by a surgeon. Distraction osteogenesis involves making an osteotomy through the bone and then slowly moving the bone ends apart. The result is a stretching of the bone callus so that new bone is generated in the gap. This technique is well-established and follows the principles of llizarov. (See Addendum A Osteogenesis Research…
Read the full statement (323 words)
The inter-Os Bone Generator™ is an implantable device for distraction osteogenesis techniques in the facial bones implanted by a surgeon. Distraction osteogenesis involves making an osteotomy through the bone and then slowly moving the bone ends apart. The result is a stretching of the bone callus so that new bone is generated in the gap. This technique is well-established and follows the principles of llizarov. (See Addendum A Osteogenesis Research Bibliography)
The Inter-Os Bone Generator™ is used to treat conditions where bone growth is deficient. The types of deformities that fall into this category are:
various forms of otomandibular syndrome, hemifacial microsomia,
Treacher-Collins syndrome, condylar agenesis, craniosynostosis,
Apert's syndrome, Crouzon’s syndrome, Pfeiffer's syndrome, etc.
The application of the device is done in place of bone grafting to augment deficient areas of bone growth. The advantages of distraction bone generation are that the patient is spared the morbidity of additional surgical sites and native autogenous bone is formed. The device can also be used in post-traumatic deformities, such as condylar fractures in children.
The Bone Generator™, therefore, is intended to be used in the various bones of the craniofacial region, such as the mandible, zygoma, maxilla, frontal bone, parietal bone, and the temporal bone. It is not the current intended use to apply the Bone Generator™ to the long bones of the limbs or in the spine, but only to the bones of the craniofacial region.
The Bone Generator™ is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after distraction stabilization is 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 meant to be fixated 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993869: Inter-OS Bone Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993869
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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