(50 days)
No
The summary describes a mechanical fixation system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as a "temporary implant" intended to "provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures" within orthopedic surgery. These functions directly contribute to the treatment or management of an injury or disease (fractures, spinal deformities), fitting the definition of a therapeutic device.
No
The device is a fixation system used in orthopedic surgery to provide temporary stabilization and aid in the repair of bone fractures, not to diagnose a condition.
No
The device description explicitly states it consists of "temporary implants" and "associated manual surgical instruments," which are physical hardware components.
Based on the provided information, the HILINE™ Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "temporary implants for use in orthopedic surgery" to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical implants (bands and clamps) made of various materials (PET, titanium alloy, etc.) and associated surgical instruments. This aligns with a surgical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The HILINE™ Fixation System is a surgical implant used for mechanical support and stabilization within the body.
N/A
Intended Use / Indications for Use
The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;
· Spinal degenerative surgery, as an adjunct to spinal fusions;
· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.
The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Product codes
OWI
Device Description
The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
patients 8 years of age and older
Intended User / Care Setting
orthopedic surgery
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
Mechanical testing (static and dynamic tension, band pull-through, rod pushthrough, and static component torsion) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K133482, K172417, K153348, K182771, K213659
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
April 20, 2023
Globus Medical Inc. Dr. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K230565
Trade/Device Name: HILINE™ Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: OWI Dated: February 28, 2023 Received: March 1, 2023
Dear Jennifer Antonacci:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230565
Device Name HILINETM Fixation System
Indications for Use (Describe)
The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
· Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis;
· Spinal degenerative surgery, as an adjunct to spinal fusions;
· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.
The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary: HILINE™ Fixation System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Antonacci, Ph.D.
Group Manager, Regulatory Affairs |
| Date Prepared: | April 17, 2023 |
| Device Name: | HILINETM Fixation System |
| Common Name: | Bone Fixation Cerclage, Sublaminar |
| Classification: | Per 21 CFR as follows:
§888.3010 Bone Fixation Cerclage
Product Code: OWI
Regulatory Class: II, Panel Code: 87 |
| Primary
Predicate: | SILC® Fixation System (K133482) |
| Additional
Predicates: | SILC® Fixation System (K172417)
Implanet JAZZTM LOCK (K153348)
Implanet JAZZTM CAP SP (K182771)
Medicrea LigaPASSTM 2.0 (K213659) |
| Reference
Device: | CREOTM Stabilization System (K124058, K180210) |
Purpose:
The purpose of this submission is to request clearance for the HILINE™ Fixation System.
Device Description:
The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.
4
Indications for Use:
The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring . techniques;
- . Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis:
- . Spinal degenerative surgery, as an adjunct to spinal fusions;
- Use with a posterior spinal instrumentation construct when ligament . augmentation is needed.
The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Performance Data:
Mechanical testing (static and dynamic tension, band pull-through, rod pushthrough, and static component torsion) was conducted in accordance with ASTM F1798. Performance data demonstrate substantial equivalence to the predicate devices.
Technoloqical Characteristics:
The HILINE™ Fixation System has similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
The HILINE™ Fixation System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate devices.