(14 days)
Not Found
No
The summary describes a mechanical bone screw and does not mention any software, algorithms, or AI/ML related terms.
No.
The device is a compression bone screw, which is a mechanical device used for stability and compression in fusions, fractures, or osteotomies. It does not provide therapy in the medical sense (e.g., drug delivery, energy delivery, or biological intervention).
No
The device description indicates it is a bone screw used for treatment (compression across a fracture site), not for diagnosing a condition.
No
The device description clearly states it is a "Compression Bone Screw," which is a physical implantable hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The EBI® DynaFix® Compression Bone Screw is a surgical implant used to fix bones directly within the body. It is a medical device, but not an in vitro diagnostic device.
The provided information clearly describes a device intended for surgical implantation to treat bone issues, not for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The EBI® DynaFix® Compression Bone Screws are indicated for fusions, fractures, or osteotomies of the Upper and Lower Extremities.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
Description of the device: The EBI® DynaFix® Compression Bone Screw is intended to be inserted across the fracture site. The EBI® DynaFix® Compression Bone Screw will provide compression across the fracture site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and Lower Extremities
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
MAR 2 0 2003
030706
page 1 of 2
510(k) Summarv
This 510(k) Summary for the EBI® DynaFix® Compression Bone Screws is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
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- Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Contact Person: Frederic Testa Phone: (973)299-9300, ext. 2208
- Submitter: EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Date prepared: March 3, 2003
| 2. Proprietary Name: | EBI® DynaFix® Compression Bone Screw |
|---|---|
| Common Name: | Internal Fixation Device |
| Classification Names: | Smooth or Threaded Metallic Bone |
| Fixation Fastener, 21 CFR 888.3040 |
-
- Predicate or legally marketed devices that are substantially equivalent:
- Description of the device: The EBI® DynaFix® Compression Bone Screw is 4. intended to be inserted across the fracture site. The EBI® DynaFix® Compression Bone Screw will provide compression across the fracture site.
-
- Intended Use: The EBI® DynaFix® Compression Bone Screws are indicated for fusions, fractures, or osteotomies of the upper and lower extremities.
1
- Materials: The components of the System may be manufactured from stainless steel as per ASTM F-899.
7. Comparison of the technological characteristics of the device to predicate
devices: There are no significant differences between the EBI® DynaFix®
Compression Bone Screws and other currently marketed internal fixation systems. It
is substantially equivalent* to the predicate device in regards to intended use,
materials, and function.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
MAR 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frederic Testa, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054
Re: K030706
Trade/Device Name: EBI® DynaFix® Compression Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 3, 2003 Received: March 6, 2003
Dear Mr. Testa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
L. Mark N. Melkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
Page 1 looof old
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: EBI® DynaFix® Compression Bone Screw
Indications For Use:
The EBI® DynaFix® Compression Bone Screws are indicated for fusions, fractures, or osteotomies of the Upper and Lower Extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Mark N Millann
Division Sign-Off Division of General. Restorative and Neurological Dovices
510(k) Number K030706