(119 days)
Not Found
No
The summary describes a mechanical plating system for orthopedic correction and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is designed to correct angular deformities in pediatric patients, which is a therapeutic intervention.
No
Explanation: The device is described as a "Growth Control Plating System" designed for "redirecting the angle of growth of long bone(s)" and "correcting angular deformities." This indicates a therapeutic or interventional purpose rather than a diagnostic one.
No
The device description explicitly states that the system consists of physical components: two plate designs and screws. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Peanut™ Growth Control Plating System is a surgical implant designed to physically alter the growth of bones in pediatric patients. It is used in vivo (within the living body) to correct anatomical deformities.
The provided information clearly describes a surgical device used for orthopedic procedures, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Peanut™ Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients (patients who have not had physeal closure/reached skeletal maturity). 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); 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, HWC
Device Description
The Peanut™ Growth Control Plating System consists of two plate designs (arched and stepped) and solid and cannulated screws.
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 (patients who have not had physeal closure/reached skeletal maturity), pediatric patients with an open physis.
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)
Pull-out strength testing was provided to support 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
K093880 (pg 1/2)
Biomet Trauma Traditional 510(k) Premarket Notification APR 1 & 2010
| 1 | ||
|---|---|---|
| 100 |
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter: | Biomet Trauma
100 Interpace Parkway
Parsippany, NJ 07054 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 2242816 |
| Contact: | Margaret F. Crowe
Regulatory Affairs Project Manager
Biomet Trauma
100 Interpace Parkway
Parsippany, NJ 070654
Tel.: 973-299-9300, ext. 2260
Fax: 973-257-0232
E-mail: margaret.crowe@biomet.com |
| Date Prepared: | April 15, 2010 |
| Trade/Proprietary Name: | Peanut™ Growth Control Plating System |
| Common/Usual Name: | Plates/Screws |
| Classification Name: | Single/multiple metallic bone fixation appliances and
accessories (21 CFR 888.3030) |
| Device Panel/Product Code: | Orthopedics HRS/HWC |
Device Description:
The Peanut™ Growth Control Plating System consists of two plate designs (arched and stepped) and solid and cannulated screws.
Indications for Use:
The Peanut™ Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients (patients who have not had physeal closure/reached skeletal maturity). This is useful for gradually correcting angular deformities in pediatric
Page 5-2
1
Biomet Trauma Traditional 510(k) Premarket Notification
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).
Purpose of Submission
The purpose of this submission is to:
- Add 16mm screw lengths .
- Add a contraindication to the previously cleared labeling for the Peanut™ Growth . Control Plating System
- Allow the implants of the Peanut™ system to be sold in a non-sterile configuration . either packaged individually or in a kit/tray packaging configuration.
The contraindications for the Peanut™ Growth Control Plating System are:
-
- Physeal closure/skeletal maturity
-
- Active Infection
-
Patient conditions including blood supply limitations, and insufficient quantity or quality of bone.
-
Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions or materials.
-
Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
The first contraindication is being added to the labeling to limit the use of the device to the intended population.
Summary of Technologies:
The technological characteristics of the Peanut™ Control Plating System are the same, or similar to, other legally marketed predicate devices. The Orthofix eight-Plate device is distributed in a non-sterile configuration, and has a similar contraindication in its 510(k) summary.
Substantial Equivalence:
The modifications to the Peanut™ Growth Control Plating System do not raise any issues of safety or effectiveness. The modified product is equivalent to the Growth Control Plating System released in premarket notification K070823, and to the Orthofix eight-Plate previously released under K031493. Pull-out strength testing was provided to support substantial equivalence.
2
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Trauma (aka EBI LP) % Margaret F. Crowe 100 Interpace Pkwy. Parsippany, New Jersey 07054
APR 1 6 2010
Re: K093880
Trade/Device Name: Peanut Growth Control Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 15, 2010 Received: April 16, 2010
Dear Ms. Crowe:
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 r ou may, increases, and 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 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 r lease be devised that i Dr rivieran that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I coural butther and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de receited adverse overs) (2 regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by south of Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Margaret F. Crowe
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Barbara Buettner
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 4093BBO (pa 1/1)
Device Name: Peanut™ Growth Control Plating System
The Peanut™ Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients who have not had physeal closure/reached skeletal maturity). 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); 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).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Temperature
Barbara Buerkle
(Division Sign-Off) Diveron of Engical, Orthopedic, and Restorative Devices
510(k) Number K093880