(30 days)
Not Found
Not Found
No
The summary describes a system of bone plates and screws made of stainless steel for fracture fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as "intended for fracture fixation," which is a corrective measure rather than a therapeutic one aimed at treating, mitigating, or preventing disease.
No
Explanation: The device is described as "fracture fixation" hardware, not a tool for diagnosing medical conditions. It is used for treatment, not diagnosis.
No
The device description explicitly lists physical components made of stainless steel (plates), indicating it is a hardware medical device for fracture fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Osteo BOS" System is described as a system of stainless steel components (plates) intended for fracture fixation of long and small bones. This is a surgical implant used directly on the body to stabilize broken bones.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, laboratory procedures, or diagnostic information derived from samples.
Therefore, based on the provided information, the Osteo BOS" System is a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Osteo BOS" System in Stainless Steel components are intended for fracture fixation of long and small bones.
The indications for use of the Osteo BOS" System in Stainless Steel bone plates, in keeping with those of other legally marketed bone plates and bone screws, are as follows.
- The Osteo BOS" System in Stainless Steel components are intended for long and small bone ● fracture fixation.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Osteo BOS" System in Stainless Steel components are used for fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from ASTM F-138-92 Stainless Steel and include the following:
- Plate Wide (06.5mm/04.5mm)
- Plate - Narrow (06.5mm/04.5mm)
- Plate Wide (04.0mm/03.5mm) .
- One-Third Tubular Plate (e4.0mm/03.5mm)
- Plate (@2.7mm)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long and small bones
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
USTEDNICS-REG AFFAIRS SEP-19-1997 09:55 FRONI
516
SEP 25 1997 K973204
TO
y
oods Revision
Osteo BOS" System in Stainless Steel
510(k) Premarket Notification
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO BOS" SYSTEM IN STAINLESS STEEL
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677
201-825-4900 |
|--------------------------------------------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Kate Sutton
Regulatory Affairs Specialist |
| Date Summary Prepared: | September 19, 1997 |
| Device Identification | |
| Proprietary Name: | Osteo BOS ™ System in Stainless Steel |
| Common Name: | Stainless Steel Plating System |
| Classification Name and Reference: | Plate, Fixation, Bone
21 CFR §888.3030 |
Predicate Device Identification
The subject Osteo BOS® System in Stainless Steel components are substantially equivalent to similar bone plates offered by Synthes.
Device Description
The Osteo BOS" System in Stainless Steel components are used for fracture fixation of long and small bones. All Osteo BOS" System components are manufactured from ASTM F-138-92 Stainless Steel and include the following:
- Plate Wide (06.5mm/04.5mm) �
- � Plate - Narrow (06.5mm/04.5mm)
- Plate Wide (04.0mm/03.5mm) .
- One-Third Tubular Plate (e4.0mm/03.5mm) �
- Plate (@2.7mm) �
1
16/16
Osten BQS " System in Stainless Steel
510(k) Premarket Notification
Intended Use
The Osteo BOS" System in Stainless Steel components are intended for fracture fixation of long and small bones.
TC
Statement of Technological Comparison
The subject Osteo BOS" System in Stainless Steel components are substantially equivalent in design and intended use to the predicate bone plates offered by Synthes. Both the subject and predicate plates are manufactured from stainless steel.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kate Sutton 'Requlatory Affairs Specialist Osteonics 59 Route 17 Allendale, New Jersey 07401-1677
SEP 2 5 1997
Re: K973204 Osteo BOSTM System in Stainless Steel Regulatory Class: II Product Code: HRS Dated: August 25, 1997 Received: August 26, 1997
Dear Ms. Sutton:
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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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.
3
Page 2 - Ms. Kate Sutton
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witton, Ph. D.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| 510(k) Number (if known): | K973204 |
|---|---|
| --------------------------- | --------- |
Device Name: Osteo BOS" System in Stainless Steel
Indications For Use:
The indications for use of the Osteo BOS" System in Stainless Steel bone plates, in keeping with those of other legally marketed bone plates and bone screws, are as follows.
- The Osteo BOS" System in Stainless Steel components are intended for long and small bone ● fracture fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| restorative Devices K973204 |
|---|
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use ______ | |
| (Optional Format 1-2-96) |