(42 days)
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, a PediPlate™ system, is used for fracture fixation, correction of deformity, and redirection of growth in bones, which are therapeutic interventions.
No
The device is described as a system for fracture fixation and correction of bone deformities, which are therapeutic and reconstructive functions, not diagnostic ones.
No
The device description clearly states it is a system of physical plates and screws made of 316L stainless steel, which are hardware components.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OrthoPediatrics PediPlate™ system is a surgical implant used for the physical fixation of bones during fracture healing and deformity correction. It is a mechanical device that is surgically placed within the body.
- Intended Use: The intended use clearly describes surgical procedures and the physical support of bone structures. There is no mention of testing biological samples.
Therefore, the function and intended use of the OrthoPediatrics PediPlate™ system fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OrthoPediatrics PediPlate™ system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children.
Specific pediatric conditions/diseases for which the devices 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 (humerus)
- Radial or ulnar deviation, flexion or extension deformities of the wrist (radius)
Product codes
HRS, HWC, OBT
Device Description
The two and four-hole plates feature a contoured mid-section and low profile for pediatric use. There is an alignment mark or small provisional fixation hole in the center of the O. H and I-Plates to aid accurate placement of the device relative to the growth plate that is localized radiographically. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is transfixed to bone using two to four screws, depending on which plate is selected.
- Materials: The devices are manufactured from 316L stainless steel, which meet ASTM F138 or ASTM F139.
- Function: The system functions to provide immediate stability and temporary . fixation during the natural healing process.
The OrthoPediatrics PediPlate TM System is intended for use in the treatment of pelvic, small and long bone fractures, as well as deformity corrections of pediatric patients' long bones, which includes osteotomies, and redirecting the angle of growth of children's long bones. The system includes cortical and cannulated screws, and specialty plates, referred to as O, 1, and H-Plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, small and long bone, tibia, fibula, femur, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand, middle foot bones, calcaneal, hip, knee, ankle, elbow, wrist
Indicated Patient Age Range
adult and pediatric patients, growing children
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K081407, K073344, K031493, K020221, K993106, K000684, K013248, K080522
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the number '0', then the number '9', another '0', and then three consecutive '6's. The characters are written in a bold, slightly irregular style, giving them a casual, handwritten appearance.
Page 1 of 2
APR 2 4 2009
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | OrthoPediatrics, Corp.
210 N. Buffalo Street
Warsaw, Indiana 46580
Establishment Registration No.: 9102640 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Gary Barnett
VP-Regulatory, Engineering & Operations
Tel: (574) 268-6379
Fax: (574) 269-3692 |
| TRADE NAME: | OrthoPediatrics PediPlates ™ System |
| COMMON NAME: | Plate, Fixation, Bone |
| CLASSIFICATION: | Single/multiple component metallic bone fixation
appliances and accessories: Class II per 21 CFR
§888.3030 |
DEVICE PRODUCT CODE(S): HRS and HWC
SUBSTANTIALLY EQUIVALENT DEVICES: -------
- K081407, PediPlate TM Plating System, OrthoPediatrics .
- K073344, PediPlate TM Plating System, OrthoPediatrics
- K031493, Guided Growth Plate, Marketed by Orthofix
- K020221, IQL Stainless Steel Plates, Biomet ●
- K993106, TC-100 Plating and Screw System, Smith & Nephew .
- K000684, Small Fragment DCL System, Synthes .
- K013248, LCP Distal Tibial Plates, Synthes .
- K080522, LCP Distal Tibial T-plates, Synthes
DEVICE DESCRIPTION:
The two and four-hole plates feature a contoured mid-section and low profile for pediatric use. There is an alignment mark or small provisional fixation hole in the center of the O. H and I-Plates to aid accurate placement of the device relative to the growth plate that is localized radiographically. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is transfixed to bone using two to four screws, depending on which plate is selected.
- Materials: The devices are manufactured from 316L stainless steel, which meet ASTM F138 or ASTM F139.
1
- Function: The system functions to provide immediate stability and temporary . fixation during the natural healing process.
The OrthoPediatrics PediPlate TM System is intended for use in the treatment of pelvic, small and long bone fractures, as well as deformity corrections of pediatric patients' long bones, which includes osteotomies, and redirecting the angle of growth of children's long bones. The system includes cortical and cannulated screws, and specialty plates, referred to as O, 1, and H-Plates.
INDICATIONS FOR USE:
The OrthoPediatrics PediPlate™ system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting anqular deformities in growing children.
Specific pediatric conditions/diseases for which the devices 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 (humerus) .
- Radial or ulnar deviation, flexion or extension deformities of the wrist (radius) .
BASIS FOR SUBSTANTIAL EQUIVALENCE:
OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications.
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 eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
APR 2.4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OrthoPediatrics, Corporation % Mr. Gary Barnett VP-Regulatory, Engineering & Operations 210 N. Buffalo St Warsaw, Indiana 46580
Re: K090666
Trade/Device Name: OrthoPediatrics 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, HWC, OBT Dated: March 10, 2009 Received: March 13, 2009
Dear Mr. Barnett:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Mr. Gary Barnett
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
lkerson
Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): KD90 جاڪل جا
Device Name: OrthoPediatrics Plating System
The OrthoPediatrics PediPlate™ system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children.
Specific pediatric conditions/diseases for which the devices 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 (humerus)
- Radial or ulnar deviation, flexion or extension deformities of the wrist (radius)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
|--|
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Number | K090666 |
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| Page | 1 of 1 |
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