(76 days)
Not Found
Not Found
No
The summary describes standard bone plates for fracture fixation and does not mention any AI or ML components or functionalities.
No
The device is described as anatomical bone plates intended for internal fracture fixation, which is a structural support function rather than a therapeutic one.
No
Explanation: The device is described as an internal fracture fixation device, which is a therapeutic function rather than a diagnostic one. It is used to fix fractures, not to identify or monitor medical conditions.
No
The device description explicitly states that the device is manufactured from stainless steel and includes various types of physical plates, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Osteo Anatomical Bone Plates are intended for internal fracture fixation of various long bones. This is a surgical implant used within the body to stabilize fractures, not a device used to test samples outside the body.
The information provided aligns with a Class II or Class III medical device used in orthopedic surgery, not an IVD.
N/A
Intended Use / Indications for Use
The plates that comprise the Osteo Anatomical Bone Plates are intended for the following uses: Internal fracture fixation of various long bones. .
The indications for the use of these bone plates, in keeping with those of other legally marketed bone plates, are as follows. The Osteo Anatomical Bone Plates are intended for internal fracture fixation of various long . bones.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Osteo Anatomical Bone Plates are used for fracture fixation on various long bones. All Osteo Anatomical Bone Plates are manufactured from stainless steel and include the following: Form Plates Humeral Plates ● Plates for Multi-Condylar Fragments ACP Plates for Distal Femur ACP ● Trochanter Hip Plates ACP Narrow and Wide Elongation Plates ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various long 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
Osteo Anatomical Bone Plates
510(k) Premarket Notification | of 2
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEO ANATOMICAL BONE PLATES
AUG 25 1997
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: | June 6, 1997 |
Device Identification
| Proprietary Name: | Osteo Anatomical Bone Plates |
|---|---|
| Common Name: | Bone Plates |
| Classification Name and Reference: | Plate, Fixation, Bone |
| 21 CFR §888.3030 |
Predicate Device Identification
The subject Osteo Anatomical Bone Plates are substantially equivalent to similar bone plates offered by Waldemar Link GmbH & Co. and Synthes.
Device Description
The Osteo Anatomical Bone Plates are used for fracture fixation on various long bones. All Osteo Anatomical Bone Plates are manufactured from stainless steel and include the following:
- Form Plates
- Humeral Plates ●
- Plates for Multi-Condylar Fragments ACP
- Plates for Distal Femur ACP ●
- Trochanter Hip Plates ACP
- Narrow and Wide Elongation Plates ●
1
Intended Use
The plates that comprise the Osteo Anatomical Bone Plates are intended for the following uses:
- Internal fracture fixation of various long bones. .
Statement of Technological Comparison
The subject Osteo Anatomical Bone Plates are substantially equivalent in design and intended use to the predicate bone plates offered by Waldemar Link GmbH & Co., Synthes, and Osteo AG. All subject and predicate plates are manufactured from stainless steel.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three human profiles forming its body. The profiles are stacked on top of each other, creating a sense of unity and collaboration. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kate Sutton Regulatory Affairs Specialist Osteonics, Inc. 59 Route 17 Allendale, New Jersey 07401-1677
AUG 25 1997
K972196 Re: Osteo Anatomical Bone Plates Requlatory Class: II Product Code: HRS Dated: June 6, 1997 Received: June 10, 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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.
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 requlation (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,
Celia M. Witten, 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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510(k) Number (if known): K972196
Device Name: Osteo Anatomical Bone Plates
Indications For Use:
The indications for the use of these bone plates, in keeping with those of other legally marketed bone plates, are as follows.
- The Osteo Anatomical Bone Plates are intended for internal fracture fixation of various long . bones.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-2-96) -
Acotes
Divisi Sign-Off) Division of General Restorative Devices Kg 510(k) Number