# K993869: Inter-OS Bone Generator

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Os Technologies, LLC
- Decided: Jan 19, 2000 after 65 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Howmedica Leibinger MID System: named in the summary without a submission number
- (no number) Synthes Mandibular Distractor: named in the summary without a submission number
- (no number) KLS Martin Mandibular Distractor: named in the summary without a submission number
- (no number) Howmedica Mandibular Distractor: named in the summary without a submission number

## Most influential descendants
- K031875: Inter-OS Limb Lengthener (2003), 4 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own
- K193617: Precice® Screws (2020), 0 descendants of its own
- K051162: Generos SB Small Bone Distraction Implant (2005), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K993869
Methodology: https://510kreport.com/methodology