(64 days)
No
The device description and intended use are purely mechanical, describing a physical coupler for spinal rods. There is no mention of any computational or analytical functions that would involve AI/ML.
Yes.
Explanation: The device is intended to treat various spinal conditions, including severe spondylolisthesis, unstable spinal fractures, degenerative disk diseases, and spinal curvatures, by providing temporary stability and support during bony fusion healing.
No
Explanation: The device is a 'Rod-To-Rod Coupler' intended to form a transverse connection between spinal rods to increase torsional stiffness. It is a surgical implant designed to provide mechanical support and stability to the spine, not to identify or determine the nature of a disease or condition.
No
The device description and intended use clearly describe a physical implantable medical device (Rod-To-Rod Coupler) used in spinal surgery, not a software-only product.
Based on the provided information, 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 and Intended Use: The description clearly states that the Rod-To-Rod Coupler is a physical device intended to be implanted surgically into the spine to provide structural support and stability. It is a mechanical component used in a surgical procedure.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing biological samples from the patient.
Therefore, the Rod-To-Rod Coupler falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Rod-To-Rod Coupler is intended to form a transverse connection between spinal rods in a spinal construct in order to increase the torsional stiffness of the construct.
A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the Versalok Posterior Spinal Fixation System components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
-
- Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
-
- Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by history and radiographic studies);
-
- Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
- . Progressive, despite other forms of treatment,
- . Detrimental to cardiopulmonary function,
- . Interfering with spinal mechanics or causing severe back pain, or
- . Cosmetically unacceptable, progressive, and painful.
The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
Product codes (comma separated list FDA assigned to the subject device)
MNH, KWP
Device Description
The coupler is designed to form a transverse connection between spinal construct in order to increase the torsional stiffness of the construct. All the components are made from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and sacral spine (L3 to S1), fifth lumbar - first sacral (L5-S1) vertebral joint, thoracic, thoracolumbar, or lumbar spine (T1 to S1)
Indicated Patient Age Range
Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
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)
Submitted testing demonstrates that the Rod-To-Rod Coupler fatigue performance is comparable to a predicate device and adequate for its intended use.
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.
DePuy Motech MOSS Miami Spinal System, SYNTHES (USA) Universal Modular Spinal Syster
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.
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
Attachment F
Image /page/0/Picture/1 description: The image is a logo of a stylized letter "W" formed by three triangles. The two outer triangles are solid black, while the middle triangle is white, creating the "W" shape. A registered trademark symbol is located at the bottom right corner of the logo.
510(k) Summary
ARLINGTON.
AIRLINE
Contact Person: Date Prepared:
Lynne Witkowski March 31, 1998
Device Name: System Name: Predicate Device: Rod-To-Rod Coupler Versalok Posterior Spinal Fixation System DePuy Motech MOSS Miami Spinal System, SYNTHES (USA) Universal Modular Spinal Syster
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR $807.92.
Intended Use
A construct with screws attached to the pedicles of the lumbar and sacral spine (1.3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (LS-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the Versalok Posterior Spinal Fixation System components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
- Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors; 1.
- Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with 2. degeneration of the disk confirmed by history and radiographic studies);
- Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with 3. associated paralysis or spasticity, and secondary to spinal fractures) which are:
- Progressive, despite other forms of treatment, t
- Detrimental to cardiopulmonary function,
- Interfering with spinal mechanics or causing severe back pain, or
- Cosmetically unacceptable, progressive, and painful.
The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
Description
The coupler is designed to form a transverse connection between spinal construct in order to increase the torsional stiffness of the construct.
Materials
All the components are made from stainless steel.
Testing Summary
Submitted testing demonstrates that the Rod-To-Rod Coupler fatigue performance is comparable to a predicate device and adequate for its intended use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with three stripes representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1998
Ms. Lynne Witkowski ·Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re : K980496 Rod-to-Rod Couplers - part of the Versalok Posterior Spinal Fixation System (K950074 and K961572) Requlatory Class: II Product Codes: MNH and KWP February 6, 1998 Dated: February 9, 1998 Received:
Dear Ms. Witkowski:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act). found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.
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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.
2
Page 2 - Ms. Lynne Witkowski
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than Fination, additions is, as described above, is a class III Bevice Sponalisonesia)(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for Dyboom as (a) having severe spondylolisthesis (Grades 3 pacience: (a) fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- When used as a pedicle screw system, this device . system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended . for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- Benefit of spinal fusions utilizing any pedicle . screw fixation system has not been adequately established in patients with stable spines. ________
- Potential risks identified with the use of this ● device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
3
Page 3 - Ms. Lynne Witkowski
See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of র্বাচন করে এ বার বিশ্ববিদ্যালয়ের প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্রায় প্ previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
4
This letter will allow you to begin marketing your device as This letter will allow you co begin maification immediately.
described in your 510 (k) premarket notification indexico to described in your 310(x) promains of your device to a All FDA Linding Of Subscancial ogarresults in a classification legally marketed predicate active device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on compriance ac (sol, devertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stephen Rhodes
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
Wright Medical Technology, Inc. Premarket Notification Wright Medical Technology Rod-To-Rod Cou
C. Indications for Use of the Device
510(k) Number (if known):
Rod-To-Rod Coupler Device Name: Versalok Posterior Spinal Fixation System System Name:
Indications for Use:
The Rod-To-Rod Coupler is intended to form a transverse connection between spinal rods in a spinal construct in order to increase the torsional stiffness of the construct.
A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the Versalok Posterior Spinal Fixation System components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
-
- Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
-
- Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by history and radiographic studies);
-
- Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
- . Progressive, despite other forms of treatment,
- . Detrimental to cardiopulmonary function,
- . Interfering with spinal mechanics or causing severe back pain, or
- . Cosmetically unacceptable, progressive, and painful.
The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
(Please do not write below this line * * *
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X Or Over-the-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
Stephen Elvords
(Division Sign-Off)
Division of General Restorative Devices K980496
510(k) Number