(50 days)
Not Found
No
The device description and performance studies focus solely on the mechanical components and structural integrity of a pedicle screw system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a pedicle screw system intended for the immobilization of spinal segments as an adjunct to fusion, and is indicated for various acute and chronic instabilities or deformities such as degenerative disc disease, spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion. These are conditions that involve the treatment or management of a disease or medical condition.
No
The device is a pedicle screw fixation system intended to provide immobilization of spinal segments as an adjunct to fusion. Its purpose is to physically support and stabilize the spine, not to identify or diagnose medical conditions.
No
The device description clearly outlines physical components made of titanium alloy, such as rods, screws, and connectors, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "pedicle screw fixation system" intended to provide "immobilization of spinal segments" as an "adjunct to fusion." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details physical components like rods, screws, and connectors made from titanium alloy. These are all components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Lium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic imparment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyhosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intents diagnosed with: spondylolisthesis / spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Eminent Spine Scoliosis Deformity Pedicle System consists of rods, polyaxial screws with set caps, and cross connectors with locking screws. Additionally, the system consists of rod connectors and iliac bolts with their respective locking screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to various increments. Cannulated polyaxial screws are available in 6.0mm to 12.5mm diameters and in lengths ranging from 40mm to 110mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods. Rod connectors are offered in 3 types and the iliac bolts are offered in 1 type. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S2/Ilium
Indicated Patient Age Range
skeletally mature patients
pediatic 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)
Mechanical Testing:
Construct tests were conducted according to ASTM F1717, including static torsion, static compression bending, and dynamic compression bending. Rod connector axial and torsional grip tests were conducted according to ASTM F1789. Results support the substantial equivalence of the subject device compared to predicate devices.
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.
Eminent Spine Diamondback Pedicle Screw System (K100377), NEXXT Spine Inertia® Pedicle and Deformity Correxxion System (K153453)
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
September 3, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Eminent Spine Stephen Courtney Chief Executive Officer 2004 Ventura Dr. Ste. 100 Plano, Texas 75093
Re: K242069
Trade/Device Name: Eminent Spine Scoliosis Deformity Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: August 15, 2024 Received: August 16, 2024
Dear Stephen Courtney:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Eileen
Digitally signed by
Eileen Cadel -S
Date: 2024.09.03
Cadel -S 11:13:15 -04'00'
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
for
2
Enclosure
2
Indications for Use
510(k) Number (if known) K242069
Device Name
Eminent Spine Scoliosis Deformity Pedicle Screw System
Indications for Use (Describe)
The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Lium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (DDD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic imparment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyhosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intents diagnosed with: spondylolisthesis / spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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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3
Image /page/3/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a spine-like structure in the middle of the blade. The sword is surrounded by a golden, crescent-shaped design. The text "EMINENT" is written in a bold, serif font above the word "SPINE", which is written in a smaller, lighter font.
510(k) Summary
| Submitted By: | Eminent Spine, LLC
2004 Ventura Dr. Suite #100
Plano, TX 75093 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 08/20/2024 |
| Contact Person:
Contact Telephone:
Contact Fax: | Stephen Courtney, CEO, Eminent Spine
(972) 499-3593
N/A |
| Device Trade Name:
Common Name:
Device Classification Name:
Device Classification:
Reviewing Panel:
Product Code:
Primary Predicate Device:
Additional Predicate Devices: | Eminent Spine Scoliosis Deformity Pedicle Screw System
Pedicle Screw Spinal System
Orthosis, spinal pedicle fixation
Class II - 21 CFR 888.3070 - Thoracolumbarsacral Pedicle Screw System
Orthopedic
NKB
Eminent Spine Diamondback Pedicle Screw System (K100377)
NEXXT Spine Inertia® Pedicle and Deformity Correxxion System (K153453) |
Device Description:
The Eminent Spine Scoliosis Deformity Pedicle System consists of rods, polyaxial screws with set caps, and cross connectors with locking screws. Additionally, the system consists of rod connectors and iliac bolts with their respective locking screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and pre-contoured rods are each offered in lengths ranging from 40mm to various increments. Cannulated polyaxial screws are available in 6.0mm to 12.5mm diameters and in lengths ranging from 40mm to 110mm in 5mm increments. Set caps are used to fasten the rod and screw. Cross connectors are available in 3 length ranges: 32mm-42mm, 42mm-58mm, and 58mm-74mm. Cross connectors lock screws are used to fasten the cross connector together and fasten across the rods. Rod connectors are offered in 3 types and the iliac bolts are offered in 1 type. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy per ASTM F136.
Indications for Use:
The Eminent Spine Scoliosis Deformity Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium). The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DD) (defined as back pain with discogenic origin with degeration of the disc confirmed by history and radiographophic studies), severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebrae, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis and failed previous fusion.
When used for fixation to the ilium, the offset connectors of the Eminent System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Eminent Spinal Scoliosis Deformity Pedicle Screw System is indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Eminent Spine Deformity Pedicle System is intended to treat pediatric patients diagnosed with: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
4
Image /page/4/Picture/1 description: The image shows a logo for "Eminent Spine". The logo features a stylized spine with a sword running through it, all encased within a golden, semi-circular frame. The word "EMINENT" is written in a bold, sans-serif font above the word "SPINE", which is written in a smaller, lighter font. The overall design is professional and suggests a focus on spinal health or surgery.
Technological Characteristics Comparison
The technological design features of the subject Eminent Spine Scoliosis Deformity Pedicle Screw System is substantially equivalent to the predicate devices (K100377 and K153453). The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent
Mechanical Testing:
Substantial equivalence is supported by the results of mechanical testing. Construct tests were conducted according to ASTM F1717, including static torsion, static compression bending, and dynamic compression bending. Rod connector axial and torsional grip tests were conducted according to ASTM F1789. Results support the substantial equivalence of the subject device compared to predicate devices.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence for its intended use.