(36 days)
Not Found
No
The description focuses on mechanical and magnetic mechanisms for limb lengthening and fracture fixation, with no mention of AI or ML technologies.
Yes
The device is indicated for limb lengthening, fracture fixation, and other conditions affecting long bones, which are therapeutic interventions.
No
The device is described as an implanted system for limb lengthening and fracture fixation, which are therapeutic interventions, not diagnostic processes.
No
The device description explicitly lists hardware components such as the PRECICE STRYDE Nail, locking screws, end caps, surgical instruments, and an external remote controller (ERC). While the ERC might contain software, the system as a whole is a physical medical device with mechanical components for limb lengthening and fracture fixation.
Based on the provided information, the PRECICE STRYDE System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical procedures involving limb lengthening, fracture fixation, and bone transport of long bones. This is a therapeutic and structural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an implantable nail and associated instruments used for mechanical manipulation of bone. It does not involve the analysis of biological samples.
- Performance Studies: The performance studies described are mechanical tests (strength, torsion, etc.) to demonstrate the structural integrity and function of the device, not clinical studies evaluating the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The PRECICE STRYDE System does not perform this function.
N/A
Intended Use / Indications for Use
The PRECICE STRYDE System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC
Device Description
The PRECICE STRYDE System includes the PRECICE STRYDE Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE STRYDE nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE STRYDE Nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE STRYDE Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE STRYDE Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.
The purpose of this submission is to implement design changes to the predicate PRECICE System (K173129) to create a product line extension which includes the PRECICE STRYDE Nail and compatible locking screws and end caps. These design changes meet improved performance specifications which allow for modification of the device labeling; specifically, the contraindications, warnings, and precautions regarding maximum patient weight and ERC/tissue gap. These modifications to the PRECICE System do not change the indications for use or intended use of the device, nor do they change the fundamental scientific technology of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
Indicated Patient Age Range
Not Found
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 performance verification testing was performed to demonstrate that the subject PRECICE STRYDE System is substantially equivalent to the predicate device. The following testing was performed: Static Compression Bending Strength, Dynamic Compression Bending strength, Torsion, Torque Resistance, Axial Pullout, Tensile Strength, Distraction Force. The applicable standards for these tests were ASTM F1264 and ASTM F543. The results demonstrate that the subject PRECICE STRYDE System is substantially equivalent to the predicate.
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in blue, followed by "U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.
NuVasive Specialized Orthopedics, Inc. Lance Justice Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
April 3. 2018
Re: K180503
Trade/Device Name: PRECICE STRYDE System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: February 22, 2018 Received: February 26, 2018
Dear Lance Justice:
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. 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name PRECICE STRYDE System
Indications for Use (Describe)
The PRECICE STRYDE System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf shape in purple and gray on the left. To the right of the leaf is the company name, "NUVASIVE," in gray, with the words "SPECIALIZED ORTHOPEDICS, INC." in smaller purple font underneath.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
A. Submitted by:
Lance Justice Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (949) 544-6540
Date Prepared: February 22, 2018
B. Device Name
| Trade or Proprietary Name: | PRECICE® STRYDE™ System |
|---|---|
| Common or Usual Name: | Intramedullary Fixation Rod |
| Classification Name: | Rod, Fixation, Intramedullary and Accessories |
| Screw, Fixation, Bone |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3020 and 888.3040 |
| Product Code: | HSB, HWC |
C. Predicate Devices
The subject PRECICE STRYDE System is substantially equivalent to the predicate device, PRECICE System (K173129).
D. Device Description
The PRECICE STRYDE System includes the PRECICE STRYDE Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE STRYDE nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE STRYDE Nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE STRYDE Nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE STRYDE Nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.
The purpose of this submission is to implement design changes to the predicate PRECICE System (K173129) to create a product line extension which includes the PRECICE STRYDE Nail and compatible locking screws and end caps. These design changes meet improved performance specifications which allow for modification of the device labeling; specifically, the contraindications, warnings, and precautions regarding maximum patient weight and ERC/tissue
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Image /page/4/Picture/0 description: The image contains the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic on the left, followed by the word "NUVASIVE" in gray, sans-serif font. Below "NUVASIVE" is the text "SPECIALIZED ORTHOPEDICS, INC." in a smaller, purple, sans-serif font.
gap. These modifications to the PRECICE System do not change the indications for use or intended use of the device, nor do they change the fundamental scientific technology of the device.
E. Intended Use
The PRECICE STRYDE System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
F. Comparison of Technological Characteristics with the Predicate Device
As was established in this submission, the subject PRECICE STRYDE System is substantially equivalent to the predicate PRECICE System (K173129) previously cleared by the FDA for commercial distribution in the United States. There have been no design changes to the implants previously cleared in the predicate 510(k)s. The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Nonclinical performance verification testing was performed to demonstrate that the subject PRECICE STRYDE System is substantially equivalent to the predicate device. The following testing was performed
| Testing Description | Applicable Standard |
|---|---|
| Static Compression | |
| Bending Strength | ASTM F1264 - Standard Specification and Test |
| Methods for Intramedullary Fixation Devices | |
| Dynamic Compression | |
| Bending strength | |
| Torsion | |
| Torque Resistance | ASTM F543 - Standard Specification and Test |
| Methods for Metallic Medical Bone Screws | |
| Axial Pullout | |
| Tensile Strength | N/A |
| Distraction Force | N/A |
The results demonstrate that the subject PRECICE STRYDE System is substantially equivalent to the predicate.
H. Conclusions
The subject PRECICE STRYDE System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.