K Number
K990944
Device Name
OSTEOMED INTRAORAL DISTRACTION SYSTEM
Manufacturer
Date Cleared
1999-06-16

(86 days)

Product Code
Regulation Number
872.4760
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions mav include diagnoses such as mandibular micrognathia or hemifacial microsomia.
Device Description
The OsteoMed Intraoral Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm bone screws. The distractor is available in right and left versions: The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 25mm.
More Information

Not Found

No
The device description focuses on mechanical components and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Yes

The device is indicated for treatment (mandibular distraction osteogenesis) of specific medical conditions (mandibular micrognathia or hemifacial microsomia), making it a therapeutic device.

No

This device is described as a mandibular bone lengthener and a subcutaneous bone distractor, used for treatment (mandibular distraction osteogenesis); it does not perform diagnostic functions like identifying or analyzing a medical condition.

No

The device description clearly describes a physical, subcutaneous bone distractor with various hardware components (bars, threaded wire, screw holes, bone screws, hex driver).

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's a "mandibular bone lengthener" used for "mandibular distraction osteogenesis." This is a surgical procedure performed directly on the patient's bone.
  • Device Description: The description details a "subcutaneous bone distractor" with physical components (bars, threaded wire, screws) that are implanted to lengthen bone.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.

This device is a surgical implant used for a therapeutic purpose (bone lengthening), not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

This submission describes the OsteoMed Intraoral Distraction System indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions mav include diagnoses such as mandibular micrognathia or hemifacial microsomia.

Product codes

MQN

Device Description

The OsteoMed Intraoral Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm bone screws. The distractor is available in right and left versions: The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 25mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Mandibular

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

K964649, K972166

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.4760 Bone plate.

(a)
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.(b)
Classification. Class II.

0

K9909444

Image: OSTEOMED CORPORATION logo
510(k) Summary
Device Proprietary Name:OsteoMed Intraoral Distraction
System
Device Common Name:Intraoral Distractor
specialized
orthopaedic
productsClassification Name:MQN, External Mandibular
Fixator and/or Distractor
craniofacial
reconstruction
productsName of Submitter:OsteoMed Corporation
3750 Realty Road
Addison, Texas 75001
Phone: (972) 241-3401
Fax: (972) 241-3507
new product
developmentContact Person:Dawn T. Holdeman
Date Prepared:March 19, 1999
Summary:

This submission describes the OsteoMed Intraoral Distraction System indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions mav include diagnoses such as mandibular micrognathia or hemifacial microsomia.

The OsteoMed Intraoral Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm bone screws. The distractor is available in right and left versions: The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 25mm.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and the Howmedica Guerrero-Bell Distractor (K972166).

Due to the similarity of materials and design to both pre-enactment and postenactment devices. OsteoMed believes that the OsteoMed Intraoral Distraction System does not raise any new safety or effectiveness issues.

1

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1999

Ms. Dawn T. Holdeman Document Control and Regulatory Affairs OsteoMed Corporation 3750 Realty Road Addison, Texas 75001

Re : K990944 OsteoMed Intraoral Distraction System Trade Name: Regulatory Class: II Product Code: MON Dated: March 19, 1999 Received: March 22, 1999

Dear Ms. Holdeman:

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 Requlations, 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 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.

2

Page 2 - Ms. Holdeman

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 diagnostic 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 qeneral 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

ge ol

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Osteomed Intraoral

Indications For Use:

Indicated for use as a mandibular bone Indicated for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rosiner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)