(42 days)
No
The device description and intended use focus on mechanical components (plates and screws) for bone growth redirection. There is no mention of AI, ML, image processing, or data-driven analysis in the provided summary.
Yes
The device is intended to correct angular deformities in pediatric patients, which is a therapeutic intervention.
No
The device is described as a "Plating System" used for "redirecting the angle of growth of long bone(s)" to correct "angular deformities." This indicates a therapeutic or corrective function, not a diagnostic one.
No
The device description explicitly states that the system consists of "plates and screws," which are physical hardware components made of Ti-6Al-4V.
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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (plates and screws) used to physically correct bone deformities in pediatric patients. It is a mechanical device used in vivo (within the body), not in vitro (in a lab setting with specimens).
The device's function is to mechanically influence bone growth, which is completely different from the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients. This is useful for gradually correcting anqular deformities in pediatric patients with an open physis. Specific conditions/ diseases for which the device will be indicated include valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Product codes
HRS
Device Description
The Growth Control Plating System consists of plates and screws, all of which are comprised of Ti-6Al-4V.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone(s), knee (femur and/or tibia), ankle, elbow, wrist (radius)
Indicated Patient Age Range
pediatric patients
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)
Non-Clinical Testing; Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
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
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
510(k) Summary
MAY - 7 2007
| Preparation Date: | March 23, 2007 |
|---|---|
| Applicant/Sponsor: | Biomet Trauma (formerly known as EBI Trauma) |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Contact Person: | Debra L. Bing |
| Director, Regulatory Affairs | |
| Biomet Trauma | |
| 973.299.9300 | |
| Proprietary Name: | Growth Control Plating System |
| Common Name: | Pediatric orthopedic implant |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories, 21 CFR §888.3030, HRS |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Guided Growth Plate K031493 University of Utah School of Medicine
Device Description: The Growth Control Plating System consists of plates and screws, all of which are comprised of Ti-6Al-4V.
Intended Use: The Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients. This is useful for gradually correcting anqular deformities in pediatric patients with an open physis. Specific conditions/ diseases for which the device will be indicated include valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Summary of Technologies: The technological characteristics of the Growth Control Plating System are the same as, or similar to, the predicate device.
Non-Clinical Testing; Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Trauma % Ms. Susan Alexander Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw. Indiana 46581-0587
MAY - 7 2007
Re: K070823
Trade/Device Name: Growth Control Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 23, 2007 Received: March 26, 2007
Dear Ms. Alexander:
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 - Ms. Susan Alexander
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Boehm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Growth Control Plating System
Indications For Use:
The Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients. This is useful for gradually correcting angular deformities in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valqus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over - The - Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Darbar Buehr
- Restorative, and Neurological Devices
510(k) Number K070823
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