(86 days)
Not Found
No
The device description and intended use focus on a physical implant (intramedullary rod) made of stainless steel for fracture stabilization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
Explanation: The device is used to stabilize fractures and aid in the healing process of bones, which aligns with the definition of a therapeutic device that treats or prevents a disease or condition.
No
Explanation: The device is an intramedullary rod used to stabilize fractures of the femoral shaft and other long bones. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the device is an intramedullary rod (nail) made of medical grade stainless steel, which is a physical hardware component.
Based on the provided text, the OrthoPediatrics PediNail™ system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- PediNail™ Function: The description clearly states that the PediNail™ is an intramedullary rod inserted into the body (specifically the femur) to stabilize fractures. It is a surgical implant used for mechanical support and fixation.
The intended use and device description focus entirely on the physical stabilization of bone fractures within the patient's body, not on analyzing biological samples outside the body.
N/A
Intended Use / Indications for Use
The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail ™ is for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel.
The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting, supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.
- 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
Femoral shaft, femurs, long bones
Indicated Patient Age Range
pediatric and small stature adult 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)
Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
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.
K040929, K070843, K983942, K993956, K072161, K040336
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
K083726 #1/2
MAR 1 1 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 PediNailTM Intramedullary Nailing
System |
| COMMON NAME: | Intramedullary nail |
| CLASSIFICATION: | 21 CFR 888.3020: Intramedullary fixation rod and
accessories: Class II per 21 CFR §888.3020 |
DEVICE PRODUCT CODE(S): HSB
SUBSTANTIALLY EQUIVALENT DEVICES:
K040929, Tri-Gen Adolescent TAN, Smith & Nephew
K070843, Adolescent Lateral Entry Nail, Synthes
K983942, Intramedullary Nail System (stainless steel), Smith & Nephew
K993956, Titanium Pediatric Femoral Nail, Biomet
K072161, Femoral Locking Nail System, Biomet
K040336, Lateral Entry Femoral Nail System, Synthes
DEVICE DESCRIPTION:
OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel.
The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of
1
K083726 #2/2
impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting, supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.
- 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 PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail 116 is for single use only.
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.
Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
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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 three overlapping wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.
MAR 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthopediatrics, Corp. % Mr. Gary Barnett VP, Regulatory & Medical Affairs 210 North Buffalo Street Warsaw, Indiana 46580
Re: K083726
Trade/Device Name: OrthoPediatrics PediNail™ Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 10, 2008 Received: December 15, 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
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 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,
Sana Ahmed. for.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): KO 83776
Device Name: OrthoPediatrics PediNail ™ Intramedullary Nailing System
The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted. spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ---------------------------------------------- | --- |
AND/OR
| 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)
| S/m D. | |
|---|---|
| -- | --------------- |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| s10(k) Number | Page 1 |
|---|---|
| --------------- | -------- |
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