(60 days)
Not Found
No
The description focuses on mechanical components and a remote controller for adjusting the device, with no mention of AI or ML capabilities.
Yes
The device addresses medical conditions such as limb lengthening, fracture fixation, and non-unions, indicating its therapeutic purpose in treating or alleviating these conditions.
No
The device is described as an implantable system for limb lengthening and bone fixation, not for diagnosing medical conditions. It performs a therapeutic function (bone transport) rather than a diagnostic one.
No
The device description explicitly lists hardware components such as the bone transport nail, locking screws, end caps, surgical instruments, and an external remote controller (ERC). It also describes the physical mechanism of the nail and the ERC's function in adjusting it.
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.
- Precice® Bone Transport System Function: The description clearly states that this system is an implantable device used for surgical procedures on long bones (limb lengthening, fracture fixation, etc.). It is used within the body to physically manipulate and stabilize bone.
The information provided describes a surgical implant and its associated tools, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Precice® Bone Transport 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® Bone Transport System includes the Precice® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The Precice ® Bone Transport nails, screws and end caps are supplied sterile by gamma radiation while the 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 of the intercalary bone segment and providing internal fixation for fractures of long bones. The Precice® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The Precice® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted noninvasively by the External Remote Controller (ERC). The Precice ® Bone Transport 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 introduce design modifications to the distal portion of the Precice ® Bone Transport 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® Bone Transport 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
Retention Force Testing
Distraction Force
The results demonstrate that the subject Precice® Bone Transport 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size.
NuVasive Specialized Orthopedics, Inc. Madison Heffron Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
Re: K201567
Trade/Device Name: Precice® Bone Transport System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: June 9, 2020 Received: June 11, 2020
Dear Madison Heffron:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
August 10, 2020
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K201567
Device Name
Precice® Bone Transport System
Indications for Use (Describe)
The Precice® Bone Transport 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic to the left of the company name, "NUVASIVE," in silver lettering. Below the name, in smaller purple letters, is the text "SPECIALIZED ORTHOPEDICS, INC."
Precice® Bone Transport System 510(k) Summary
A. Submitted by:
Madison Heffron Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (949) 532-7868
Date Prepared: June 8, 2020
B. Device Name
| Trade or Proprietary Name: | Precice® Bone Transport System |
|---|---|
| Common or Usual Name: | Intramedullary Fixation Rod |
| Classification Name: | Intramedullary Fixation Rod |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3020 |
| Product Code (primary): | HSB |
| Product Code (additional): | HWC |
C. Predicate Devices
The subject Precice® Bone Transport System is substantially equivalent to the primary predicate device, Precice® Bone Transport System (K193016).
D. Device Description
The Precice® Bone Transport System includes the Precice® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The Precice ® Bone Transport nails, screws and end caps are supplied sterile by gamma radiation while the 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 of the intercalary bone segment and providing internal fixation for fractures of long bones. The Precice® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The Precice® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted noninvasively by the External Remote Controller (ERC). The Precice ® Bone Transport 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.
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Image /page/4/Picture/0 description: The image is a logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray graphic to the left of the company name. The company name is in gray, with the words "SPECIALIZED ORTHOPEDICS, INC." in smaller purple font below.
The purpose of this submission is to introduce design modifications to the distal portion of the Precice ® Bone Transport device.
E. Indications for Use
The Precice® Bone Transport 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® Bone Transport System is substantially equivalent to the predicate Precice ® Bone Transport System (K193016) previously cleared by the FDA for commercial distribution in the United States. 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® Bone Transport 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 | |
| Retention Force Testing | N/A |
| Distraction Force | N/A |
The results demonstrate that the subject Precice® Bone Transport System is substantially equivalent to the predicate.
H. Conclusions
The subject Precice® Bone Transport System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.