(59 days)
Not Found
No
The summary describes a mechanical bone plate system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for "temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions and non-unions," which directly addresses and treats a physical condition.
No
The device is described as an "internal fixation and stabilization" system for bone fractures and osteotomies, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it combines "implants and instruments," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a system of implants (bone plates) and instruments used for the surgical fixation and stabilization of bone fractures and osteotomies. This is a surgical implant/device used directly on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "temporary internal fixation and stabilization of long bone fractures and osteotomies." This is a therapeutic and structural function, not a diagnostic one.
Therefore, based on the provided information, the OrthoPediatrics Fracture and Osteotomy Bone Plate System is a surgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The OrthoPediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.
Product codes
HRS, HWC
Device Description
The OrthoPediatrics Fracture and Osteotomy Bone Plate System will combine implants and instruments in one convenient system. This system will offer the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, intertrochanteric, femoral neck, pertrochanteric.
Indicated Patient Age Range
pediatric and small stature 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
Engineering calculations with worst case loading calculations of subject device and corresponding predicate device, confirmed that subject device has equivalent or better strength and resistance to bending moments. A review of the MAUDE complaint data base of similar predicate devices support the safety and effectiveness of the device.
Key Metrics
Not Found
Predicate Device(s)
K062872, K072095, K083286, K082949, K100240, K070906, K003496
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 - K111086
JUN 1 7 2011
SUMMARY OF SAFETY AND EFFECTIVENESS
April 15, 2011 - Revised June 7, 2011
| NAME OF FIRM: | OrthoPediatrics, Corp.
2850 Frontier Drive
Warsaw, Indiana 46582
Establishment Registration No.:3006460162 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Mark Fox
Vice President of Regulatory Affairs
Tel: (574) 268-6379
Fax: (574) 269-3692 |
| TRADE NAME: | OrthoPediatrics Fracture and Osteotomy
Bone Plate System |
COMMON NAME: Bone Plates and Bone Screws
RECOMMENDED CLASSIFICATION:
21 CFR 888.3030: Single/Multiple components metallic bone fixation appliances and accessories: Class II per 21 CFR §888.3030
21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener: Class II per 21 CFR §888.3040
Recommended Class: II
| DEVICE PRODUCT CODE(S): | HRS, (Plate. Fixation, Bone) |
|---|---|
| HWC, (Screw, Fixation, Bone) |
DEVICE DESCRIPTION:
The OrthoPediatrics Fracture and Osteotomy Bone Plate System will combine implants and instruments in one convenient system. This system will offer the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety.
1
INDICATIONS FOR USE:
The OrthoPediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions and non-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.
PREDICATE DEVICES:
K062872, Pediatric LCP Hip Plate System, Synthes (USA)
K072095, Pediatric LCP Hip Plate System Modifications, Synthes (USA)
K083286, PediLoc Locking Plate System, Orthopediatrics
K082949, OrthoPediatrics Bone Screws, OrthoPediatrics
K100240, PediLoc Tibial Plate System, OrthoPediatrics K070906, Periarticular Locking Plate System, Zimmer K003496, Cannulated Screw System, Pioneer
MATERIALS:
.
All implant components are manufactured from medical grade metals including 316L stainless steel which meets the ASTM-F138 standard. In addition, the cannulated screws are manufactured from medical grade BIODUR stainless steel which meets ASTM 2229-07 standard.
TECHNOLOGIC CHARACTERISTICS:
The fundamental scientific principles and technological characteristics, including the intended use, material, sizes, and general design are the same as, or similar to, the predicate devices.
Summary of technological characteristics:
- Plate thickness(s) and width(s) are substantially equivalent to predicates.
-
- Identical materials to cited predicates.
-
- Range of plate angles are substantially equivalent to predicates.
-
- Range of screw sizes and threads are substantially equivalent to predicates.
- Indications for Use is substantially equivalent to predicates.
The technological characteristics of the subject device and the predicates are substantially equivalent to the predicates.
2
PERFORMANCE ANALYSIS:
Subject device has similar configuration, sizes and design as the predicate device(s). Engineering calculations with worst case loading calculations of subject device and corresponding predicate device, confirmed that subject device has equivalent or better strength and resistance to bending moments. A review of the MAUDE complaint data base of similar predicate devices support the safety and effectiveness of the device.
FUNCTION:
The system functions to provide immediate stability and temporary fixation during the natural healing process.
EQUIVALENCY:
Therefore, since materials, intended use, and technological features used in the OrthoPediatrics Fracture and Osteotomy Bone Plate System are similar to the predicate devices, safety and efficacy is expected to be equivalent.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OrthoPediatrics, Corporation % Mr. Mark Fox Vice President of Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582
2017 1 1 אטע
Re: K111086
Trade/Device Name: OrthoPediatrics Fracture and Osteotomy Bone Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 15, 2011 Received: April 19, 2011
Dear Mr. Fox:
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 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 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
4
Page 2 - Mr. Mark Fox
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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
fa
Mark N. Melke Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KIII086 (11/1)
Indications for Use Statement
510(k) Number: K111086
Device Name: OrthoPediatrics Fracture and Osteotomy Bone Plate System
The OrthoPediatrics Fracture and Osteotomy Bone Plate System is intended for temporary internal fixation and stabilization of long bone fractures and osteotomies, mal-unions, in pediatric and small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Po. Am. Nor.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111086