(113 days)
No
The device description focuses on the mechanical components (plates, screws) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes.
The device is intended for the fixation of fractures, nonunions, replantations, and fusions of small bone fragments, which are therapeutic applications.
No
The device is described as a plate and screw system intended for fixation of fractures, nonunions, replantations, and fusions of small bone fragments. Its purpose is to physically stabilize and correct existing conditions, not to diagnose them.
No
The device description explicitly details physical components such as plates, screws, and instruments made from various materials, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are 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 the OrthoPediatrics PediFoot Deformity Correction System as a system of plates and screws intended for the fixation of fractures, nonunions, replantations, and fusions of small bone fragments within the body. This is a surgical implant used directly on the patient's anatomy.
The device's function is mechanical support and stabilization within the body, not the analysis of biological samples outside the body.
N/A
Intended Use / Indications for Use
OrthoPediatics PediFoot Deformity Correction System is intended for fixation of fractures, nonunions, replantations, and fusions of small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Product codes
HRS
Device Description
The OrthoPediatics PediFoot Deformity Correction System is a plate and screw system intended for the use in fracture fixation, osteotomies, and arthrodesis, primarily in the foot. The subject plates system will offer five different plate options – compression/neutral plates, reconstruction plates, wedge plates, clover plates and angle iron plates in various sizes to accommodate patient anatomy. All plates will be sized to allow their use in children and small statured adults. The plates are designed to accept the subject Ø2.7mm or Ø3.5mm cortical and/or variable angle locking screws. All subject plates and screws are manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139. All instruments are manufactured from stainless steel per ASTM F899, cobalt chrome per ASTM F562, silicone, propylux, polyphenylsulfone, or aluminum per ASTM B209, B211, or B221.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, foot, and ankle
Indicated Patient Age Range
children and small statured adults
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
Non-Clinical Tests:
- Torque to Failure per ASTM F543
- Driving Torque per ASTM F543
- Axial Pullout per ASTM F543
- Bone Plate Bend Testing per ASTM F382
- Variable Angle Screw/Plate Interface Testing, including bending strength and push out strength
Testing demonstrated the subject device to be substantially equivalent to predicate Synthes Modular Foot System (K001941) and Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System (K100776).
The OrthoPediatrics PediFoot Deformity Correction System was evaluated for use in an MR Environment and were determined to be MR Conditional.
Clinical Tests: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K050110, K063049, K100776, K131186, K001941
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.
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August 6, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
OrthoPediatrics, Corp Jen Gregory Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582
Re: K190992
Trade/Device Name: OrthoPediatrics PediFoot Deformity Corrections System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: July 1, 2019 Received: July 5, 2019
Dear Jen Gregory:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
OrthoPediatrics PediFoot Deformity Correction System
Indications for Use (Describe)
OrthoPediatics PediFoot Deformity Correction System is intended for fixation of fractures, nonunions, replantations, and fusions of small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the OrthoPediatrics PediFoot Deformity Correction System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'The New 510(k) Paradigm – Alternate Approaches to Demonstration Substantial Equivalence in Premarket Notifications – Final Guidance', issued on March 20, 1998.
| Sponsor: | OrthoPediatrics, Corp.
2850 Frontier Drive
Warsaw, IN 46582
Establishment Registration Number: 9102640
Phone: (574) 267-0880
Fax: (574) 269-3692 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jen Gregory
Regulatory Affairs Manager |
| Date: | June 26, 2019 |
| Subject Device: | Trade Name: OrthoPediatrics PediFoot Deformity Correction System
Regulation Number: 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories
Product Code: HRS
Common Name: Plate, Fixation, Bone |
Legally marketed devices to which substantial equivalence is claimed:
Primary Predicate:
- K050110 – Synthes LCP Modular Foot Plates
Secondary Predicates:
- K063049 - Synthes Modular Mini Fragment LCP System
- K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System
- . K131186 – Synthes 2.7/3.5 Variable Angle LCP Midfoot/Hindfoot
- K001941 – Synthes Modular Foot System
Device Description
The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw system intended for the use in fracture fixation, osteotomies, and arthrodesis, primarily in the foot. The subject plates
4
system will offer five different plate options – compression/neutral plates, reconstruction plates, wedge plates, clover plates and angle iron plates in various sizes to accommodate patient anatomy. All plates will be sized to allow their use in children and small statured adults. The plates are designed to accept the subject Ø2.7mm or Ø3.5mm cortical and/or variable angle locking screws. All subject plates and screws are manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139. All instruments are manufactured from stainless steel per ASTM F899, cobalt chrome per ASTM F562, silicone, propylux, polyphenylsulfone, or aluminum per ASTM B209, B211, or B221.
Intended Use and Indications for Use
OrthoPediatrics PediFoot Deformity Correction System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
Summary of Technological Characteristics
The technological characteristics (materials, design, sizing) of the subject OrthoPediatrics PediFoot Deformity Correction System are similar to the following predicate devices:
Primary Predicate:
- K050110 Synthes LCP Modular Foot Plates ●
- Secondary Predicates:
- K063049 - Synthes Modular Mini Fragment LCP System
- K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System
- K131186 – Synthes 2.7/3.5 Variable Angle LCP Midfoot/Hindfoot
- K001941—Synthes Modular Foot System
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use: The OrthoPediatrics PediFoot Deformity Correction System has the same intended use as the predicate Synthes LCP Modular Foot Plates (K050110), Modular Mini Fragment LCP System (K063049) and Synthes Modular Foot System (K001941).
- . Indications for Use: Indications for Use are similar to the predicate Synthes LCP Modular Foot Plates (K050110), Modular Mini Fragment LCP System (K063049) and Synthes Modular Foot System (K001941).
- . Materials: The proposed OrthoPediatrics PediFoot Deformity Correction System plates and screws are manufactured from 316L stainless steel conforming to ASTM F138 or ASTM F139 which is identical to the material of the predicates Synthes Modular Plates and Screws.
- Design Features: The proposed OrthoPediatrics PediFoot Deformity Correction System incorporates similar design features and size ranges as the predicate devices.
- Function: The OrthoPediatrics PediFoot Deformity Correction System is intended for use in small bones and small bone fragments, identical to the predicate devices.
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- . Sterilization: The proposed OrthoPediatrics PediFoot Deformity Correction System is provided non-sterile and requires sterilization prior to use which is the same sterilization method utilized for the predicate devices, which are provided both sterile and non-sterile.
Performance Data
- Non-Clinical Tests
- Torque to Failure per ASTM F543
- . Driving Torque per ASTM F54
- Axial Pullout per ASTM F543
- Bone Plate Bend Testing per ASTM F382
- Variable Angle Screw/Plate Interface Testing, including bending strength and push out strength
Testing demonstrated the subject device to be substantially equivalent to predicate Synthes Modular Foot System (K001941) and Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System (K100776).
- . The OrthoPediatrics PediFoot Deformity Correction System was evaluated for use in an MR Environment and were determined to be MR Conditional.
- Clinical Tests None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion
OrthoPediatrics believes that the subject device is substantially equivalent to the legally marketed predicate device based on intended use, technology, materials, as well as the mechanical testing and biocompatibility assessment.