(127 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a spinal fixation system intended as an adjunct to fusion for a variety of spinal conditions, which makes it a therapeutic device.
No
This device is a spinal fixation system intended to provide stabilization as an adjunct to fusion, not to diagnose a condition.
No
The device description explicitly states it is a "multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, transverse connectors, and rod connectors" and is manufactured from "Titanium Alloy and Cobalt Chrome". This indicates it is a hardware-based implant system, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Range Spinal System is described as a surgical implant used for posterior stabilization of the spine as an adjunct to fusion. Its intended uses are for treating various spinal conditions like trauma, stenosis, curvatures, tumors, etc.
- Lack of Specimen Handling: There is no mention of the device being used to collect, prepare, or examine any specimens from the human body.
- Surgical Implant: The device is clearly described as a system of screws, rods, and other components that are surgically implanted into the body.
Therefore, the Range Spinal System falls under the category of a surgical implant or medical device used for structural support and stabilization within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Range Spinal System is comprised of the DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following:
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DD) (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; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
MNI, KWP, MNH
Device Description
The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, transverse connectors, and rod connectors (axial, parallel and offset lateral). The screws range from 4.5mm in diameter, 20mml 10mm in length and attach to a 5.5mm rod.
Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
posterior (thoracic-lumbar) spinal, L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), posterior or anterolateral thoracolumbar
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified implants were tested were tested in static compression, static torsion and dynamic compression in accordance with ASTM F1717 and compared with the original Range Spinal System components. The modified implants were determined to be substantially equivalent to the 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.
K042635, K052398, K070229, K072914, K080792, K110991, K112037, K090230, K020709, K110991
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
i
510(k) Summary for the Range Spinal System: Mesa Modifications
This 510(k) summary for the Range Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
- Submitter : K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Contact Person : Nancy Giezen K2M. Inc. Telephone: 703-777-3155
Date Prepared: 04/18/12
| 2. Tradename: | Range Spinal System |
|---|---|
| Common Name: | Spinal Fixation System |
| Classification Name: | Pedicle Screw Spinal System (21CFR 888.3070) |
| Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) | |
| Device Product Code: | MNI, KWP, MNH |
| Regulatory Class: | Class II |
3. Predicate or legally marketed devices which are substantially equivalent :
- K2M Range Spinal System (K042635, K052398, K070229, K072914, K080792, K110991, K112037) .
- . DePuy Expedium (K090230)
- Medtronic CD Legacy (K020709) .
- . K2M Mesa Spinal System (K110991)
4. Description of the device:
The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, transverse connectors, and rod connectors (axial, parallel and offset lateral). The screws range from 4.5mm in diameter, 20mml 10mm in length and attach to a 5.5mm rod.
Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.
5. Purnose of Submission:
The modifications to the system include 4.5/5.5mm transition rods as well as additional configurations of hooks, transyerse connectors (axial, parallel and offset lateral) and screws that range from 4.0mm-7.5mm in diameter), all of which attach to a 4.5mm rod.
1
6. Intended Use:
The Range Spinal System is comprised of the DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following:
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DD) (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; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
-
- Comparison of the technological characteristics of the device to predicate and legally marketed devices : The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.
-
- Comparison of the performance data of the device to predicate and legally marketed devices : The modified implants were tested were tested in static compression, static torsion and dynamic compression in accordance with ASTM F1717 and compared with the original Range Spinal System components. The modified implants were determined to be substantially equivalent to the predicate devices.
9. Conclusion:
There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
K2M, Inc. % Ms. Nancy Giezen 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175
Re: K120099
Trade/Device Name: Range Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: April 19, 2012 Received: April 20, 2012
Dear Ms. Giezen:
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
3
Page 2 - Ms. Nancy Giezen
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120099
Device Name: Range Spinal System
Indications for Use:
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following:
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: 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; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cali O'Neill for RPJ
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
×120079 510(k) Number Page + of 1