(86 days)
Not Found
No
The description focuses on the mechanical properties and materials of a bone plate system and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is described as providing "immediate stability and temporary fixation during the natural healing process" for fractures, which is a therapeutic function.
No
Explanation: The device, the OrthoPediatrics PediLoc™ Locking Plate System, is described as providing immediate stability and temporary fixation during the natural healing process for fractures. Its intended use and function clearly indicate it is a therapeutic device used for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "Locking Plate System" made of 316L stainless steel, which are physical hardware components used for bone fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The OrthoPediatrics PediLoc™ Locking Plate System is a surgical implant used to fix bone fractures within the body. It is a mechanical device designed to provide structural support during the healing process.
- Intended Use: The intended use clearly states it is for treating bone fractures in pediatric patients. This is a therapeutic intervention, not a diagnostic test.
The information provided describes a medical device used for surgical treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
A pediatric small fragment set offers advantages of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non-locking screws Pedi-Loc will offer a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction. The OrthoPediatrics PediLocTM Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur. Materials: The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard. Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
Indicated Patient Age Range
pediatric patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K033669, K051735, K073344, K081407, K062564
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K083286 (pg. 10
JAN 30 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 & Medical Affairs
Tel: (574) 268-6379
Fax: (574) 269-3692 |
| TRADE NAME: | OrthoPediatrics PediLocTM Locking Plate System |
| COMMON NAME: | Bone Plates and Bone Screws |
| CLASSIFICATION: | 21 CFR 888.3030: Single/Multiple components
metallic bone fixation appliances and accessories:
Class II per 21 CFR §888.3030 |
DEVICE PRODUCT CODE(S): HRS and HWC
SUBSTANTIALLY EQUIVALENT DEVICES:
S&N Locking Bone Plate System (K033669), Smith & Nephew S&N Peri-Loc Locking Bone Plate System (K051735), Smith & Nephew Pedi-Plate Bone Plate System (K073344, K081407), OrthoPediatrics, Corp. Synthes Locking Compression Plate System (K062564), Synthes (USA)
DEVICE DESCRIPTION:
A pediatric small fragment set offers advantages of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non-locking screws Pedi-Loc will offer a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and
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083286 (pg. 2 of 2)
extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
- Materials: The devices are manufactured from 316L stainless steel which . meets the ASTM-F138 standard.
- . Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
INDICATIONS FOR USE:
The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, abstract style, with thick, curved lines forming its body and wings. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2009
OrthoPediatrics Corp. C/o Mr. Gary D. Barnett V.P. Regulatory & Medical Affairs 210 North Buffalo Street Warsaw, Indiana 46580
Re: K083286
Trade/Device Name: OrthoPediatrics PediLoc™ Locking Plate 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 Dated: November 5, 2008 Received: November 5, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Gary D. Barnett
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Mark M. Millican
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K083286
Device Name: OrthoPediatrics PediLoc ™ Locking Plate System
The OrthoPediatrics PediLoc™ Locking Plate System is used for pediatric patients as indicated for pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle. Indications for buttressing multifragmentary distal femoral fractures include: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(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
510(k) Numbe
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