(76 days)
Not Found
No
The summary describes a mechanical osteotomy system (plate and screws) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for "fixation following acute corrective opening wedge osteotomies in long bone," which clearly indicates a medical purpose to treat a condition.
No
The device is described as an "Osteotomy System" intended for "fixation following acute corrective opening wedge osteotomies in long bone." This indicates a therapeutic or interventional purpose (fixation) rather than a diagnostic one.
No
The device description explicitly states the system consists of a plate and bone screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone following surgery (osteotomies). This is a surgical implant, not a device used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The device consists of a plate and screws, which are physical implants used in surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents or test kits.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The EBI® DynaFix® VS™ Osteotomy System is intended for fixation following acute corrective opening wedge osteotomies in long bone.
Product codes
NDF, NDH
Device Description
The System consists of an osteotomy plate and bone screws. This submission is for the addition of plate sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone
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)
Reference Device(s)
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
AUG 1 2 2002
510(k) Summary
KO217
This 510(k) Summary for the EBI® DynaFix® VS™ Osteotomy System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.
| 1. Sponsor:
EBI, L.P.
100 Interpace Parkway
Parsippany, NJ 07054 | Contact Person: Jon Caparotta, RAC
Telephone: (973) 299-9300, ext.3964 |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Date Prepared: | May 24, 2002 |
| 2. Proprietary Name: | EBI® DynaFix® VSTM Osteotomy System |
| Common Name: | Bone Plate and Accessories |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories, 21 CFR 888.3030. |
3. Predicate or Legally Marketed Devices:
- EBI® DynaFix® VSTM Osteotomy System (K010551) .
4. Description of Device:
The System consists of an osteotomy plate and bone screws. This submission is for the addition of plate sizes.
5. Intended Use:
The EBI DynaFix® VS™ Osteotomy System is intended for fixation following acute corrective opening wedge osteotomies in long bone.
6. Materials:
The components of the System are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.
1
7. Comparison of the technological characteristics of the device to predicate devices:
There are no significant differences between the modified EBI DynaFix® VS™ Osteotomy System and the currently marketed System. The EBI DynaFix VS Osteotomy System is substantially equivalent* to the predicate device in regards to intended use, material, 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
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, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2002
Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI. L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K021749
Trade/Device Name: EBI® DynaFix® VS™ Osteotomy System Regulation Number: 21 CFR §888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: NDF and NDH Dated: May 24, 2002 Received: May 28, 2002
Dear Mr. Caparotta;
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.
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Page 2 - Mr. Jon Caparotta, RAC
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 531-542 of the Act); 21 CFR 1000-1050.
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Sincerely yours,
Mark A. Millman
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
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Statement of Indications for Use
Page 1 of 1
510(k) Number.(if known):
Device Name: EBI® DynaFix® VSTM Ostcotomy System
Indications For Use:
The EBI® DynaFix® VS™ Osteotomy System is intended for fixation following acute corrective opening wedge osteotomies in long bone.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K021749 |
|---|---|
| --------------- | --------- |