(20 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for various spinal conditions such as scoliosis, fractures, and degenerative disc disease, which are therapeutic applications aimed at treating or alleviating these medical conditions.
No
The device description clearly states it is comprised of "single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System consists of rods, hooks, containment rings, bone screws and their accessories (blockers and caps), and transverse links." These are all components used in spinal surgery, not for diagnosing conditions. The "Intended Use / Indications for Use" section lists various spinal conditions for which the system is indicated, implying it is used for treatment of these conditions, not for their diagnosis.
No
The device description explicitly states it is comprised of physical components like rods, hooks, screws, and accessories made from Titanium Alloy. This indicates a hardware-based medical device, not a software-only one.
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: The Osteonics® Spinal System is described as a system of implants (rods, hooks, screws, etc.) made of titanium alloy, intended for surgical implantation in the spine.
- Intended Use: The intended use clearly states that the system is for stabilizing the spine in cases of scoliosis, fractures, spondylolisthesis, degenerative disc disease, etc. This is a therapeutic and structural function, not a diagnostic one performed on a sample outside the body.
The device is a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The following are specific indications for the Osteonics® Spinal System:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis .
- Vertebral fracture or dislocation
- . Spondylolisthesis
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Previously failed fusion
- . Spinal tumor
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics 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 Osteonics 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 with 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 (comma separated list FDA assigned to the subject device)
MNI, MNH and KWP
Device Description
The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System consists of rods, hooks, containment rings, bone screws and their accessories (blockers and caps), and transverse links.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Not Found
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
§ 888.3070 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
510(k) Premarket Notification
JAN 28 1999
Devi
510(k) Premarket Notification Summary of Safety and Effectiveness for the
Osteonics® Spinal System - Expanded Indications
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp.
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Kate Sutton
Regulatory Affairs Specialist |
| Date of Summary Preparation: | January 20, 1999 |
| Proprietary Name: | Osteonics® Spinal System |
| Common Name: | Spinal fixation appliance |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis
21 CFR §888.3050
Pedicle Screw System
21 CFR §888.3070 |
Predicate Device Identification
The Osteonics® Spinal System functions as the subject and predicate device. The components of the Osteonics® Spinal System were determined to be substantially equivalent via 510(k) #K951725.
Device Description
The Osteonics® Spinal System is comprised of single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI). The Osteonics® Spinal System consists of rods, hooks, containment rings, bone screws and their accessories (blockers and caps), and transverse links.
Intended Use:
The following are specific indications for the Osteonics® Spinal System:
1
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis .
- Vertebral fracture or dislocation
- . Spondylolisthesis
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Previously failed fusion
- . Spinal tumor
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics 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 Osteonics 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 with 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:
The Osteonics® Spinal System functions as both the subject and predicate device, as this submission is for expanded indications resulting from the recent downclassification to Class II of indications for use for pedicle screws.
Material:
The Osteonics® Spinal System is manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI).
Design:
The design and function of the Osteonics® Spinal System remains unchanged.
Summary
As a result of the recent downclassification of pedicle screw uses, the indications of the Osteonics® Spinal System will be expanded to include the following:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally ● mature patients, the Osteonics 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).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Ms. Kate Sutton Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K990059
Osteonics® Spinal System - expanded uses Regulatory Class: II Product Codes: MNI, MNH and KWP Dated: January 6, 1999 Received: January 8, 1999
Dear Ms. Sutton:
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 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). 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.
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 requirements, 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. Kate Sutton
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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
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
4
510(k) Number (if known): K 990059
Device Name: Osteonics® Spinal System
Indications For Use:
The uses for the legally marketed Osteonics® Spinal System are as follows:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis .
- . Vertebral fracture or dislocation
- . Spondylolisthesis
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- . Previously failed fusion
- . Spinal tumor
Pedicular Use:
- . When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics 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 Osteonics Spinal system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-S1 joint, having fusions with 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K990059 |
| Prescription Use | X | OR | Over-The-Counter Use _____ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |