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 Mizarov. (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, 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 commerciallyavailable 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.
Device Story
Implantable mechanical distraction device; treats craniofacial bone growth deficiencies via distraction osteogenesis. Features two telescoping components; threaded drive shaft; internal gear mechanism. Operated by plastic surgeon; transcutaneous pin activates drive shaft to move bone ends apart; stretches bone callus to generate new bone. Device removed after distraction stabilization. Used in clinical setting; replaces need for bone grafting; avoids morbidity of additional surgical sites; promotes native autogenous bone formation. Used with accessory bone screws; optional bone cement for stabilization on curved surfaces.
Clinical Evidence
Performance substantiated by mechanical tests, animal studies, and in vivo patient trials.
Indicated for patients with craniofacial bone growth deficiencies, including otomandibular syndrome, hemifacial microsomia, Treacher-Collins syndrome, condylar agenesis, craniosynostosis, Apert's syndrome, Crouzon's syndrome, Pfeiffer's syndrome, and post-traumatic deformities (e.g., condylar fractures in children). Used for distraction osteogenesis in facial bones (mandible, zygoma, maxilla, frontal, temporal). Not for long bones or spine.
Regulatory Classification
Identification
A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.
Predicate Devices
Howmedica Leibinger MID System
Synthes Mandibular Distractor
KLS Martin Mandibular Distractor
Howmedica Mandibular Distractor
Submission Summary (Full Text)
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JAN 1 9 2000
# K99386
# TAB 5
### 510(k) SUMMARY
# Inter-Os Technologies, L.L.C. 7144 S. Chapparal Cir. E. Aurora, CO 80016-2126
Inter-Os Technologies, L.L.C. 7144 S. Chapparal Cir. E. Inter-Os Technologies, L.L.C. Aurora, CO 80016-2126
Contact: Randolph C. Robinson, M.D.,D.D.S. 303-699-7970 303-699-7454 Fax
Summary Prepared Nov 6, 1999
Device Identification:
| Trade Name- | Inter-Os Bone Generator™ |
|----------------------|------------------------------------------------------------------------------------------------|
| Common Name- | Internal Bone Distractor |
| Classification Name- | Single/Multiple component metallic bone fixation<br>Appliance and accessories, 21 CFR 888.3030 |
The Inter-Os Bone Generator™is compared to the Howmedica Leibinger MID System, the Synthes Mandibular Distractor, the KLS Martin Mandibular Distractor, and the Howmedica Mandibular Distractor. We believe the Inter-Os device to be substantially equivalent based on the descriptive characteristics, same intended use, and same principle of operation of distraction osteogenesis, as described in the 510(k) comparative matrix included in this section.
The Inter-Os Bone Generator™ is an implantable device used to treat conditions where bone growth is deficient. It is used for the distraction osteogenesis techniques in the facial bones and implanted by a plastic surgeon. The device is to be removed after distraction is complete. It features two telescoping components that are distracted apart by a threaded drive shaft. Activation of the drive shaft is by means of a transcutaneous pin which may be removed once the distraction phase is complete. The activation pin and drive shaft are articulated using an internal gear.
All of the components of the Inter-Os Bone Generator™ are fabricated from stainless steel.
The Inter-Os Bone Generator™ is intended to be sold non-sterile. Sterilization instructions are included in the labeling. It is a single-use device.
Performance has been substantiated by mechanical tests, animal studies, and In vivo patient trials which are included in the submission.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a curved line representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2000
Randolph C. Robinson, M.D., D.D.S. Manager Inter-Os Technologies, L.L.C. 7144 South Chapparal Circle East Aurora, Colorado 80016-2126
Re : K993869 Inter-Os Bone Generator™ Trade Name: Requlatory Class: II Product Code: MON November 6, 1999 Dated: November 15, 1999 Received:
Dear Dr. Robinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Dr. Robinson
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaggov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### 510(k) Number:
## Device Name: Inter-Os Bone Generator™
#### 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 Mizarov. (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, 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 commerciallyavailable 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.
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)_________________________________________________________________________________________________________________________________________
Over-The-Counter Use_
Susan Rumer
Division Sign-Off
Division of Dental. Infection Contr 510(k) Number
100120
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
