(239 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biomechanical performance of a spinal fixation system, with no mention of AI or ML technologies.
Yes
The device is described as a "spinal intervertebral body fixation orthosis" intended to be implanted to correct conditions like "sway back, scoliosis (lateral curvature of the spine), or other conditions," and it is indicated for various spinal disorders such as "Degenerative disk disease," "Spondylolisthesis," "Fracture," and "Deformities." These uses directly address and treat medical conditions.
No
The device is described as an implantable spinal intervertebral body fixation orthosis intended for therapeutic purposes like correcting sway back or scoliosis, not for diagnosing conditions.
No
The device description explicitly states it is an implanted device made of titanium, consisting of physical components like vertebral screws, plates, and cables. 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/Indications for Use: The intended use clearly describes a device for surgical implantation to stabilize the spine and facilitate fusion. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details an implantable device made of titanium, consisting of plates, screws, and cables. This is consistent with a surgical implant, not an IVD.
- No mention of in vitro testing: There is no mention of analyzing samples (blood, tissue, etc.) or performing tests outside of the body, which is the defining characteristic of an IVD.
- Performance Studies: The performance studies focus on biomechanical testing (compression-bending, torsion, fatigue endurance) of the implant's structural integrity, not on the accuracy or reliability of a diagnostic test.
In summary, the device is a surgical implant intended for the treatment of various spinal conditions, not a device used to diagnose diseases or conditions by examining samples outside the body.
N/A
Intended Use / Indications for Use
This anterolateral/anterior system consists of several vertebral screws, locking screws, plates and rods. This anterolateral/anterior construct is intended to provide immobilization and stabilization of spinal segments as an adjunct to spinal fusion. Areas of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This anterolateral vertebral bodies of utilization during the development of a solid spinal fusion.
When used as an anterolateral/anterior spine plate and rod system, the MaCs™ modular anterior construct system is indicated for patients with:
- Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis
- Spondylolysis
- Fracture
- Spinal stenosis
- Spillar schools
- Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or related to deficient posterior elements)
- Tumors (neoplastic disease)
- Pseudarthrosis
- Failed previous fusion surgery
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eyetype screw. The device is used to apply force to a series of vertebrae to correct sway back, scoliosis (lateral curvature of the spine), or other conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Lumbar and Thoracic spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facilities and physicians
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)
Biomechanical Testing:
- Compression-Bending Test: Satisfactory results.
- Torsion Test: Satisfactory ultimate torque of the plate and rods.
- Fatigue Endurance: Satisfactory fatigue endurance of the rod and plate constructs, and pairs of rods.
Results and Conclusions:
- Stiffness of the plate system is equivalent to that of the rod system.
- Stiffness of the plate is comparable and within required specifications.
- Fatigue performance is comparable and within required specifications.
- Performance of the macs™ system is comparable to other systems on the market based on published data review.
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
MAY = 82001
| Summary of Safety and Effectiveness Information | AESCULAP® INC. |
|---|---|
| Premarket Notification, Section 510(k) | DECEMBER 5, 2000 |
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
| Device Name: | |
|---|---|
| Trade Name: | macsTL modular anterior construct system |
| Common Name(s): | Anterior thoraco-lumbar spine plates |
| Classification Name(s): | Spinal intervertebral body fixation orthosis |
Establishment Name & Registration Number:
| Name: | Aesculap® Inc. |
|---|---|
| Number: | 2916714 |
Classification(s):
$ 888.3060 Spinal intervertebral body fixation orthosis.
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eyetype screw. The device is used to apply force to a series of vertebrae to correct sway back, scoliosis (lateral curvature of the spine), or other conditions.
Classification. Class II.
| Device Class: | Class II for all requested indications |
|---|---|
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Product Code(s): | KWQ |
Applicant Name & Address:
Aesculap® Inc. 1000 Gateway Blvd. South San Francisco, CA 94080-7028 650.876.7000 voice - 650.876.0266 fax
Company Contact:
Wilson Constantine, M.D. Aesculap® Inc. 1000 Gateway Blvd. South San Francisco, CA 94080-7028 650.876.7000 voice - 650.876.0266 fax
Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C -100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
1
Performance Standards (Section 514 compliance):
Performance Standards (Section 314 compliance).
Food and Drug Administration mandated Performance standards for anterior spine plates are not in effect. rood and Drug Ammilistiation manance Performance Standards applicable to the mass AESCOLAF® INC. Intends to compy mathe present time, various performance standards such as ASTM, ISO, QSR/CGMP and in-house SOP standards are used. In addition, AESCULAR® INC. complies with the ISO, QSNCONI and in-nouse SOF standards are are are are are and 520 of the Food, Drug, and Cosmetic Act.
Special Controls:
Special Controls.
All Class II devices are subject to Special Controls. No FDA mandated special controls are in effect at the present time.
Labeling:
The macs" modular anterior construct system discussed in this premarket notification will be manufactured for AESCULAR® INC. and labeled as such. The system will be marketed exclusively to healthcare facilities and physicians.
Surgical Technique. The surgical approach of the macs™ modular anterior construct system is similar to other anterior thoraco-lumbar plate spinal systems.
Warning: Federal (United States) Law restricts this device to sale by or on the order of a physician only.
This device is not approved for screw attachment of fixation to the posterior elements Warning: (pedicles) of the cervical, thoracic or lumbar spine.
CAUTION: Mixing of dissimilar metals can accelerate the corrosion process. The components of this system must NOT be used with implants of other material in building a construct. Components of the macs ... modular anterior construct system should NOT be used with components from any other system or manufacturer.
"Precaution: The implantation of the macs" - modular anterior construct system should be performed only by experienced spinal surgeons with specific training in the use of such spinal devices because the technique is a technically demanding procedure presenting a risk of serious injury to the patient."
Preamendments Device (legally marketed comparison device):
AESCULAP® Inc. believes that the macs" modular anterior construct system is substantially equivalent to the following spinal device system marketed by Theken Surgical.
BodyForm® - Thoraco-Lumbar Fixation System, K983622 - Theken Surgical, LLC.
Centaur™ Spinal System - K994347 - Howmedica/Osteonics/Stryker
The BodyForm® - Thoraco-Lumbar Fixation System is cleared for marketing. BodyForm® is a spinal construct made up of one plate contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. The plates are sized and designed in such a way that they will accommodate particular bone graft heights. The BodyForm® is intended to be used for the surgical treatment of spinal instability or deformity. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.
The Centaur™ Spinal System is cleared for marketing. Used anteriorly, the Centaur™ System is a spinal construct manufactured from ASTM F-136-96 titanium alloy (Ti6Al4V). The system is comprised of primary and secondary bone screws, rods, lateral connectors, plates and accessories. The Centaur™ Spinal System is intended to treat deformities of curvature, fracture, tumor, spinal stenosis, spondylosisthesis, failed previous spine surgery and degenerative disk disease. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.
2
To facilitate comparison of the macs™ modular anterior construct system to the systems identified above, a 1 0 facilitate comparison table is located at the end of the document.
Summary of Biomechanical Testing:
In the compression-bending test the results are satisfactory. In the torsion test the ultimate torque of the plate and rods is satisfactory. The fatigue endurance of the rod and plate constructs is satisfactory. I he fallgar endarance of the plate and the pairs of rods are satisfactory.
Results and Conclusions:
The stiffness of the plate system is equivalent to that of the rod system.
The stimoss of the place is comparable and within the required specifications.
The fatigue performance is comparable and within the required specifications.
These results show that the performance of the macs " system is comparable to other systems on t market when the published data are reviewed.
Summary Basis for Equivalence and Comparison Table:
Summary Dasts for Equirated on the macs 14 modular anterior construct system implant constructs Biomechanical studies conductor on the macs - nocaliar for use as a spinal fixation device system. Based on the available information concerning the referenced comparison devices, these devices are similar in that:
- The devices have the same intended use and indications for use. .
- The devices are made of the same implant alloy. .
- The devices have similar form, function, components, instruments, dimensions, geometry and features. .
The use of QSR based process controls, testing standards (ASTM F-1717 - 96 testing, materials standards (ASTM F-136, 92 and ISO 5832-3) and the similarities of the references comparison devices establish that (ASTM IFTS), 22 and 150 3052 3y and is substantially equivalent to available legally marketed anterior thoraco-lumbar spinal devices. It is believed that the anticipated clinical performance of the macs Tr modular anterior construct system is equivalent to the referenced systems.
| FEATURE | macsTL modular anterior construct system | Centaur
System | BodyForm | SE? |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------|----------|
| Indications
for Use: | degenerative disk disease defined as back pain of
discogenic origin with degeneration of the disc
confirmed by history and radiographic studies
spondylolisthesis
fracture
spinal stenosis
deformities (i.e., scoliosis, kyphosis, lordosis)
tumors
pseudarthrosis
Failed Previous Fusion Surgery | SAME | SAME | YES |
| Components: | Plate, rod, nuts & cancellous bone screws | SAME | SAME | YES |
| Sterility: | No. Steam sterilize on-site before use. | SAME | SAME | YES |
| Profile: |