(77 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an orthopedic implant for spinal stabilization and fusion, not a therapeutic device for treating disease directly.
No
The device is an implantable system designed for spinal fusion, providing immobilization and stabilization. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the device is composed of physical components made of Titanium alloy (Ti-6Al-4V ELI per ASTM F136), such as a fusion rod, spherical head, set screw, and ring nut. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a physical implant made of titanium alloy, consisting of a rod, spherical head, set screw, and ring nut. These are all components of a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device is used in vivo (inside the body) for treatment.
Therefore, the ProMIS Extension Rod System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the treatment of the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending ProMIS Fixation System to a single adjacent level.
Product codes
NKB
Device Description
The ProMIS Extension Rod System (also referred to as PER System) is composed of a fusion rod (Turret™ Rod) with a spherical head at one end and a rod on the other end. The Turret™ Rod's end is connected to a pedicle screw at the adjacent vertebrae to be fused, while the spherical head attaches to the Tulip's head of Premia Spine's pedicle screw of the existing fusion system using a designated Set Screw and a Ring Nut. The spherical head of the ProMIS Extension Rod System is designed to be positioned on Premia Spines' Slender Tulip Polyaxial Pedicle Screws. The Rod is available in two lengths 60 and 75 mm in a diameter of 6 mm. All components of the ProMIS Extension Rod System are made of Titanium alloy (Ti-6Al-4V ELI per ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature 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
The ProMIS Extension Rod System was subjected to static torsion and dynamic compression testing per ASTM F1717. All devices functioned and have substantially equivalent mechanical performance compared to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 21, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Premia Spine Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, Pennsylvania 19103
Re: K232719
Trade/Device Name: ProMIS Extension Rod System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: September 5, 2023 Received: September 5, 2023
Dear Janice Hogan:
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 QS 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 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,
Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2023.11.21
14:34:03 -05'00'
for
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
2
Indications for Use
510(k) Number (if known) K232719
Device Name ProMIS Extension Rod System
Indications for Use (Describe)
When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending the ProMIS Fixation System to a single adjacent level.
| 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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3
510(k) SUMMARY
Premia Spine's ProMIS Extension Rod System
Submitter:
Premia Spine Ltd. Giborey Israel 7 Ramat Poleg, Netanya, 4250407, Israel Phone: +972-54-8080130 Facsimile: +972-7222-81203
Contact Person: Dr. Dorit Winitz.
Date Prepared: November 20, 2023
Trade Name: ProMIS Extension Rod System
21 C.F.R 888.3070 Thoracolumbosacral pedicle screw system
NKB - Class II
Predicate Devices
Primary Predicate: ProMIS™ Fixation System by Premia Spine (K231844)
Additional Predicate: Annex™ Adjacent Level System by Spine Wave (K132403)
Intended Use / Indications for Use
When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the treatment of the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending ProMIS Fixation System to a single adjacent level.
Device Description
The ProMIS Extension Rod System (also referred to as PER System) is composed of a fusion rod (Turret™ Rod) with a spherical head at one end and a rod on the other end. The Turret™ Rod's end is connected to a pedicle screw at the adjacent vertebrae to be fused, while the spherical head attaches to the Tulip's head of Premia Spine's pedicle screw of the existing fusion system using a designated Set Screw and a Ring Nut.
4
The spherical head of the ProMIS Extension Rod System is designed to be positioned on Premia Spines' Slender Tulip Polyaxial Pedicle Screws. The Rod is available in two lengths 60 and 75 mm in a diameter of 6 mm.
All components of the ProMIS Extension Rod System are made of Titanium alloy (Ti-6Al-4V ELI per ASTM F136).
Performance Data
The ProMIS Extension Rod System was subjected to static torsion and dynamic compression testing per ASTM F1717. All devices functioned and have substantially equivalent mechanical performance compared to predicate devices..
Substantial Equivalence
ProMIS Extension Rod System is substantially equivalent to other legally marketed Pedicle Screw Spinal Systems. Specifically, the ProMIS Extension Rod System is substantially equivalent to the Annex™ Adjacent Level System (K132403) and the Company's ProMIS™ Fixation System (K231844).
The ProMIS Extension Rod System shares the same general intended use and similar indications as its predicate devices. The minor differences between the ProMIS Extension Rod its predicate's indications are within the scope of the general intended use and do not raise new questions of safety and efficacy.
The subject and predicate systems are made from the same materials, are composed of very similar components that have equivalent functions and are operated according to the same principles. The subject and predicate systems share similar accessories and surgical instrumentation set, except for surgical instruments used for MIS procedures that are applicable for ProMIS™ Fixation System and Annex™ Adjacent Level System and not applicable for the ProMIS Extension Rod System.
Minor differences in the technological characteristics do not raise new questions of safety or efficacy. Mechanical bench testing demonstrates that the ProMIS Extension Rod System performs in a substantially equivalent manner as its predicate devices.
Conclusions
The Subject ProMIS Extension Rod System is substantially equivalent to the cleared Annex™ Adjacent Level System and ProMIS™ Fixation System with respect to the general intended use, similar indications, technological characteristics, principles of operations and performance. The minor differences raise no new issues of safety or effectiveness.