(47 days)
Not Found
No
The 510(k) summary describes a purely mechanical orthopedic implant for bone fixation and makes no mention of AI, ML, image processing, or any related computational technologies.
Yes
The device is intended for fixation of diaphyseal fractures of long bones to provide stability and temporary fixation during the healing process, which directly addresses a medical condition (fractures) and facilitates recovery.
No
The device is described as an implant used for fixation of fractures, not for diagnosing medical conditions.
No
The device description clearly states it is a physical nail made of Ti-6Al-4V, intended for surgical implantation. It is a hardware device, not software.
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 is done outside of the body (in vitro).
- PediFlex function: The PediFlex Nail System is an implantable device used to fix bone fractures within the body. It provides structural support during the healing process.
The description clearly states its purpose is for the fixation of bone fractures, which is a surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The PediFlex (Flexible) Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm long, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed.
- Materials: The devices are manufactured from Ti-6Al-4V which meets ASTM F136, and ISO-5832 standards.
- 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
diaphyseal fractures of long bones
Indicated Patient Age Range
all patients (for upper extremity fractures), pediatric or small stature patients (for lower extremity fractures)
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.
Synthes EIN (K971783), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K081097 Page 1/2
JUN - 3, 2008
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 & Operations
Tel: (574) 268-6379
Fax: (574) 269-3692 |
| TRADE NAME: | OrthoPediatrics PediFlex TM Flexible Nail System |
| COMMON NAME: | Intramedullary Elastic Nail |
| CLASSIFICATION: | 21 CFR 888.3040 Smooth or threaded metallic
bone fastener: Class II per 21 CFR §888.3040 |
DEVICE PRODUCT CODE(S): HTY
SUBSTANTIALLY EQUIVALENT DEVICES:
Synthes EIN (K971783), Synthes (USA) Nancy Nail (K032687), DePuy ACE, Inc.
DEVICE DESCRIPTION:
The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm long, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed.
- . Materials: The devices are manufactured from Ti-6Al-4V which meets ASTM F136, and ISO-5832 standards.
- . Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
INDICATIONS FOR USE:
The PediFlex (Flexible) Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and
1
lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
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 Department of Health & Human Services (USA). The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2008
OrthoPediatrics, Corporation % Mr. Gary Barnett Vice President, Regulatory & Quality 210 N. Buffalo Street Warsaw, Indiana 46580
Re: K081097
Trade/Device Name: OrthoPediatrics PediFlex™ Flexible Nail System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: Class II Product Code: HTY Dated: April 16, 2008 Received: April 17, 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 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.
3
Page 2 – Mr. Gary Barnett
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 Biometric's (OSB's) Division of Postmarket Surveillance at (240)- 276-3474. For questions regarding 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 toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Matheson
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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Indications for Use Statement
510(k) Number (if known): KQ8l097
Device Name: OrthoPediatrics PediFlex ™ Flexible Nail System
The PediFlex Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.R. Ogle for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K081092