(159 days)
Not Found
No
The summary describes a conventional plating and fixation system with no mention of AI or ML capabilities.
No
The device is intended for temporary internal fixation and stabilization of bones, assisting in the healing process rather than directly treating a disease or condition in a therapeutic manner.
No
The device is described as providing temporary internal fixation and stabilization of bones, which is a treatment function, not a diagnostic one.
No
The device description explicitly states that the system "combines implants and instruments," which are physical hardware components, not software. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula." This is a mechanical function related to supporting and stabilizing bone structures within the body.
- Device Description: The description reinforces this by mentioning "conventional plating technology and fixation techniques" for providing "immediate stability and temporary fixation of bones."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory setting or point-of-care setting to analyze biological samples.
The device described is a surgical implant system used for orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unions, and non-unions in all pediatric subgroups (except neonates), and small stature adults.
Product codes
KTT, HRS, HWC, HTN
Device Description
The OrthoPediatrics' PediLoc Fragment System combines implants and instruments in one convenient and comprehensive system. This System provides immediate stability and temporary fixation of bones during the healing process with conventional plating technology and fixation techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones, short (small) bones, pelvis, and scapula
Indicated Patient Age Range
all pediatric subgroups (except neonates), 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing included mechanical laboratory (bench) testing. Static and dynamic testing in addition to FEA analysis and comparisons of the subject devices with legally marketed predicates identified within this submission were performed. Dimensional comparison review and analysis with engineering rational provided additional nonclinical supportive data. The subject devices performed as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111086, K083286, K082949, K000684
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
JUL 2 9 2014
.
| NAME OF FIRM: | OrthoPediatrics, Corp.
2850 Frontier Drive
Warsaw, IN 46582 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 16, 2014 |
| 510(K) CONTACT: | Mark Fox
Vice President, Regulatory Affairs
Tel: (574) 268-6379 |
| PROPOSED TRADE
NAME: | PediLoc Fragment System |
| DEVICE
CLASSIFICATION: | Class II; 21 CFR 888.3030 and 21 CFR 888.3040 |
| CLASSIFICATION
NAME: | Sinqle/multiple component metallic bone fixation appliances
and accessories. Smooth or threaded metallic bone fixation
fastener. |
| PRODUCT CODE: | KTT, HRS, HWC, HTN |
| DEVICE
DESCRIPTION: | The OrthoPediatrics' PediLoc Fragment System
combines implants and instruments in one convenient
and comprehensive system. This System provides
immediate stability and temporary fixation of bones
during the healing process with conventional plating
technology and fixation techniques. |
| INDICATIONS FOR
USE: | OrthoPediatrics' PediLoc Fragment System is intended
to provide temporary internal fixation and stabilization of
long bones, short (small) bones, pelvis, and scapula.
This includes fractures, osteotomies, mal-unions, and
non-unions in all pediatric subgroups (except neonates),
and small stature adults. |
| MATERIALS: | Medical grade Stainless Steel
Medical grade cobalt-chromium-molybdenum |
| PREDICATE DEVICES: | OrthoPediatrics Fracture and Osteotomy Bone Plate System
(K111086)
OrthoPediatrics PediLoc Locking Plate System (K083286)
OrthoPediatrics Bone Screws (K082949)
Synthes Small Fragment Dynamic Compression Locking
(DCL) System (K000684) |
:
1
TECHNOLOGIC CHARACTERISTICS:
PERFORMANCE DATA:
NONCLINICAL TESTING:
The fundamental scientific principles and technological characteristics, including the intended use, material, and general design, and sizes of the device are the same as, or similar to, the predicate devices.
Tests performed according to ASTM Standards, demonstrated that the device performs as well as or better than the predicate devices.
Nonclinical testing included mechanical laboratory (bench) testing. Static and dynamic testing in addition to FEA analysis and comparisons of the subject devices with legally marketed predicates identified within this submission were performed. Dimensional comparison review and analysis with engineering rational provided additional nonclinical supportive data. The subject devices performed as well as or better than the predicate devices.
CONCLUSION:
The OrthoPediatrics' PediLoc Fragment System has the same intended use and technological characteristics as the predicate devices. Therefore the OrthoPediatrics' PediLoc Fragment System is substantially equivalent for its intended use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES/USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2014
OrthoPediatrics Corporation Mr. Mark Fox V. P. Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582
Re: K140431
Trade/Device Name: PediLoc Fragment 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, HWC, HTN, KTT Dated: June 16, 2014 Received: June 17, 2014
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 gencral 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 requirements, including, but not limited to: registration and listing
3
Page 2 - Mr. Mark Fox
(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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K140431 - page 1 of 1
Indications for Use Statement
510(k) Number (if known): K140431
Device Name: OrthoPediatrics' PediLoc Fragment System
Indications for Use:
OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unlons, and non-unions in all pediatric subgroups (except neonates), and small stature adults.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ or Over-The-Counter Use
(21 CFR 807 Subpart C) (21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet标志示Frank -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140431