(30 days)
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No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used to treat specific medical conditions such as degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion, which indicates its therapeutic purpose.
No
The device description and indications for use clearly describe a surgical implant system (screws, rods, plates) used for spinal fixation. It is a treatment device, not one that identifies, classifies, or predicts diseases or conditions.
No
The device description explicitly states it is made up of screws and plates manufactured from Titanium Alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a device used for surgical implantation in the spine to provide stabilization and aid in fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a spinal implant system (screws, rods, plates, cross-connectors). These are physical devices implanted in the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Anatomical Site: The anatomical site is the spine, which is where the device is surgically implanted.
- Performance Studies: The performance study mentioned is fatigue testing, which is relevant to the mechanical integrity of an implant, not the diagnostic accuracy of a test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MAC is intended to be used with the other components of the Opus™ Spinal System.
The Opus" Spinal System is intended for fixation of the T4-S2 spine. The specific indications for the Opus" Spinal System are as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Opus "Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
Product codes
MNH, MNI
Device Description
The Opus™ Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V). The plates for the Opus™ Spinal System range from 41-75 mm in length.
Longer plates will be added to the Opus" Spinal System in order to cover the maximum of surgical configurations. The three additional subject plates will range in length from 90 -120 mm.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
T4-S2 spine, non-cervical posterior spine, L5-S1 joint, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Fatigue testing demonstrates the comparable mechanical properties of the subject Opus™ Spinal System and MAC construct to the predicate constructs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
Summary of Safety and Effectiveness Line Extension Opus Spinal System
JAN 2 5 2002
Submission Information
Device
| Name and Address of the Sponsor
of the 510(k) Submission | Howmedica Osteonics Corp
59 Route 17
Allendale, NJ 07401-1677 |
|-------------------------------------------------------------|---------------------------------------------------------------------|
| Contact Person: | Karen Ariemma
Regulatory Affairs Specialist |
| Date of Summary Preparation: | December 21, 2001 |
| ce Identification | |
| Proprietary Name: | Opus™ Spinal System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis
21 CFR 888.3050 |
| | Pedicle Screw Spinal System
21 CFR 888.3070 |
Predicate Device Identification
The Opus™ Spinal System was determined substantially equivalent via 510(k) K993402. The Multi-Axial Cross-Connector (MAC) was determined substantially equivalent for use with the Opus " Spinal System via 510(k) K013688. The Opus" Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V). The plates for the Opus™ Spinal System range from 41-75 mm in length.
Description of Device Modification
Longer plates will be added to the Opus" Spinal System in order to cover the maximum of surgical configurations. The three additional subject plates will range in length from 90 -120 mm.
Intended Use:
The MAC is intended to be used with the other components of the Opus™ Spinal System.
Indications For Use:
The Opus" Spinal System is intended for fixation of the T4-S2 spine. The specific indications for the Opus" Spinal System are as follows:
1
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Opus "Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
Statement of Technological Comparison:
Fatigue testing demonstrates the comparable mechanical properties of the subject Opus™ Spinal System and MAC construct to the predicate constructs.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Ms. Elizabeth A. Staub Vice President Quality Assurance/Regulatory Affairs/ Clinical Research Howmedica Osteonics Incorporated 59 Route 17 Allendale, New Jersey 07401-1677
K014229 Re: Trade Name: OPUSTM Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Spondylolisthesis Spinal Fixation System, Pedicle Screw Fixation System Regulatory Class: II Product Code: MNH, MNI Dated: December 21, 2001 Received: December 26, 2001
Dear Ms. Staub:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date tof 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). You may, therefore, market the provisions of the reactal controls provisions of the Act. The general controls provisions of the a . I holy sever to annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 regulation (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 action. In addition, FDA may publish further announcements 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 regulations.
3
Page 2 -- Ms. Elizabeth A. Staub
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K $ 1 4- 2 2 9
Device Name: Opus™ Spinal System
The Multi-Axis Cross-Connectors are intended to be used with the other components of the Opus "Spinal System.
Indications For Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Opus™ Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature . patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
fo Mark N. Melkerss
ral. Restorative and Neurological Devices
510(k) Number K014229
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use > OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)