(210 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests.
Yes.
The device is described as a "spinal fixation device" and is intended as an "adjunct to fusion" for various medical conditions such as degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, and failed previous fusion. These indications clearly point to its use in treating and alleviating medical conditions, which aligns with the definition of a therapeutic device.
No
The REVERE 4.5 Stabilization System is described as a spinal fixation device, intended for surgical implantation to treat various spinal conditions as an "adjunct to fusion." It consists of hardware like rods, screws, and hooks, and its purpose is mechanical stabilization and correction, not diagnosis.
No
The device description clearly lists numerous physical components made of various metal alloys (rods, hooks, screws, caps, connectors, staples, and surgical instruments). This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the REVERE 4.5 Stabilization System consists of implants (rods, screws, hooks, etc.) and associated surgical instruments. These are physical devices intended to be implanted into the body.
- Intended Use: The intended use describes the surgical procedures and conditions for which the implants are used (spinal fixation, fusion, treating deformities, etc.). This involves direct intervention within the body, not testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the REVERE 4.5 Stabilization System is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The REVERE® 4.5 Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the REVERE® 4.5 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The REVERE® 4.5 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the REVERE® 4.5 Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® or ELLIPSE® system package insert for instructions and indications of use.
Product codes
NKB, OSH, KWP, KWQ, MNH, MNI
Device Description
The REVERE® 4.5 Stabilization System consists of rods, hooks, monoaxial screws, Uniplanar screws, polyaxial screws, reduction screws, locking caps, tconnectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Screws are available in a variety of sizes to accommodate individual patient anatomy. REVERE® 4.5 implants mate with 4.5mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans iliac connectors.
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae; pedicles, or transverse process of the posterior spine.
T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. REVERE® 4.5 t-connectors may only be used with 4.5mm diameter rods. Additional connectors may be used to connect two rods, and are also secured using set screws.
REVERE 4.5 Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.
The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136. F1295, F1472, F67, F1537 and F138. All other REVERE® 4.5 implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295. F67 and F138. Due to the risk of galvanic corrosion following implantation. stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal (T1-S2/ilium, T1-L5, T8-L5)
Indicated Patient Age Range
skeletally mature patients (including small stature) and pediatric 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 (static and dynamic compression, and static torsional) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, Performance data demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K061202, K091782, K100788, K091445, K102807, K994121, K103287
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
K113395 Page 1 of 3 .
510(k) Summary: REVERE® 4.5 Stabilization System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Marie Fitzgerald
Project Manager, Regulatory Affairs |
| Date Prepared: | May 4, 2012 |
| Device Name: | REVERE® 4.5 Stabilization System |
| Classification: | Per 21 CFR as follows:
§888.3050 Spinal Interlaminal Fixation Orthosis
§888.3060 Spinal Intervertebral Body Fixation Orthosis
§888.3070 Pedicle Screw Spinal System
§888.3070 Spondylolisthesis Spinal Fixation Device System
§888.3070 Pedicle Screw Spinal System, Adolescent
Idiopathic Scoliosis
Product Codes MNH, MNI, KWQ, KWP, NKB, OSH
Regulatory Class II and III, Panel Code 87. |
| Predicate(s): | REVERE® Stabilization System K061202, K091782 &
K100788
Medtronic CD Horizon® Spinal System K091445 &K102807
Synthes Small Stature USS K994121 & K103287 |
Purpose:
The purpose of this submission is to request clearance of the REVERE® 4.5 Stabilization System for skeletally mature and pediatric indications for use.
Device Description:
The REVERE® 4.5 Stabilization System consists of rods, hooks, monoaxial screws, Uniplanar screws, polyaxial screws, reduction screws, locking caps, tconnectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Screws are available in a variety of sizes to accommodate individual patient anatomy. REVERE® 4.5 implants mate with 4.5mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod and trans iliac connectors.
1
The most common use of this screw, hook, and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws and/or lamina, pedicle or transverse process hooks.
The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws and hooks attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae; pedicles, or transverse process of the posterior spine.
T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. REVERE® 4.5 t-connectors may only be used with 4.5mm diameter rods. Additional connectors may be used to connect two rods, and are also secured using set screws.
REVERE 4.5 Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.
The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136. F1295, F1472, F67, F1537 and F138. All other REVERE® 4.5 implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295. F67 and F138. Due to the risk of galvanic corrosion following implantation. stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.
Indications for Use:
The REVERE® 4.5 Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/illium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).
2
- When used for posterior non-cervical pedicle screw fixation in pediatric patients, the REVERE® 4.5 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The REVERE® 4.5 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
- In order to achieve additional levels of fixation in skeletally mature patients, the REVERE® 4.5 Stabilization System rods may be connected to the REVERE Stabilization System (5.5mm or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® or ELLIPSE® system package insert for instructions and indications of use.
Performance Data:
Mechanical testing (static and dynamic compression, and static torsional) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, Performance data demonstrate substantial equivalence to the predicate device.
Basis of Substantial Equivalence:
The REVERE® 4.5 Stabilization System implants are similar to the predicate REVERE® Stabilization System (K061202, K091782 & K100788), Medtronic CD Horizon® Spinal System (K091445 & K102807) and Synthes Small Stature USS (K994121 & K103287) implants with respect to technical characteristics, performance, and intended use. Substantial equivalence determination of the subject system to the predicate devices is based on a dimensional and engineering analysis as well as preclinical testing. The information provided within this premarket notification supports substantial equivalence to the predicate device(s).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of a human figure in profile, with three overlapping lines forming the head and upper body. The figure is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2013
Globus Medical. Incorporated % Ms. Sarah Fitzgerald Project Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K113395
Trade/Device Name: REVERE® 4.5 Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, OSH, KWP, KWQ, MNH, MNI Dated: May 9, 2012 Received: May 10, 2012
Dear Ms. Fitzgerald:
This letter corrects our substantially equivalent letter of June 14, 2012.
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
4
Page 2 - Ms. Sarah Fitzgerald
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/4/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters are bold and black, with some decorative elements around the letters. The "D" and "K" are particularly stylized, with the "K" having a design element underneath it.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
.K113395
Page 1 of 1
Indications for Use Statement
510(k) Number:
Device Name:
REVERE® 4.5 Stabilization System
Indications:
The REVERE 4.5 Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the REVERE® 4.5 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The REVERE® 4.5 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation in skeletally mature patients, the REVERE® 4.5 Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® or ELLIPSE® system package insert for instructions and indications of use.
Prescription Use __ X (Per 21 CFR §801.109) Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Erinl Keith
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113395