(16 days)
Not Found
No
The description focuses on the mechanical components and materials of bone screws for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes.
The device is used to treat various spinal conditions, including scoliosis, vertebral fracture, spondylolisthesis, degenerative disc disease, previously failed fusion, and spinal tumor. This aligns with the definition of a therapeutic device which is intended to treat or alleviate diseases/disorders.
No
Explanation: The device is a spinal implant used for fixation and fusion, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is comprised of "single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI)," which are physical bone screws, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws clearly indicate that they are implantable surgical devices used for fixation and fusion of the spine. They are physically placed within the body during surgery.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any other activity typically associated with IVD devices.
Therefore, based on the provided information, the Osteonics® Spinal System bone screws are not IVD devices. They are surgical implants.
N/A
Intended Use / Indications for Use
The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows:
Non-Pedicular Use; fixation of the T4-S2 spine:
- Long and short curve scoliosis .
- . Vetebral fracture or dislocation
- t Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies).
- D Previously failed fusion
- Spinal tumor
Pedicular Use:
- の When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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. Pedicle screws are not intended for placement in pedicles above L3.
Product codes (comma separated list FDA assigned to the subject device)
MNH, 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 bone screws are top loading screws that are threaded distally, have a forked proximal design, and are available in both standard and extended ("extra-long" or "long arm") proximal length configurations. The 5.5mm bone screws will be available in standard and extra-long versions in lengths of 30mm, 35mm, 40mm, and 45mm. The 10.0mm bone screws will be available in one standard version only in lengths from 35mm to 60mm in increments of 5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T4-S2 spine (non-pedicular); L5-S1 joint (pedicular)
Indicated Patient Age Range
Not Found
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
SEP 25 1998
Osteonics® Spinal System - 5.5mm & 10mm Bone Screws
510(k) Premarket Notification
510(k) Premarket Notification Summary of Safety and Effectiveness for the
Osteonics® Spinal System 5.5mm &10.0mm Bone Screws
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|------------------------------------------------------------------|
| Contact Person: | Kate Sutton
Regulatory Affairs Specialist |
| Date of Summary Preparation: | August 31, 1998 |
Device Identification
Osteonics® Spinal System 5.5mm & Proprietary Name: 10.0mm Bone Screws Spinal fixation appliance Common Name: Classification Name and Reference: Spinal Interlaminal Fixation Orthosis 21 CFR §888.3050
Predicate Device Identification
The Osteonics® Spinal System, which includes bone screws, was determined to be substantially equivalent via 510(k) #K951725. The proposed 5.5mm and 10.0mm bone screws of the Osteonics® Spinal System are substantially equivalent to those bone screws in the Osteonics® Spinal System and the 5.5mm bone screws of the following competitive devices, which have previously been determined substantially equivalent by FDA:
- . Danek TSRH Spinal System
- AcroMed Titanium Bone Screws
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 bone screws are top loading screws that are threaded distally, have a forked proximal design, and are available in both standard and extended ("extra-long" or "long arm") proximal length configurations. The 5.5mm bone screws will be available in standard and extra-long versions in lengths of 30mm, 35mm, 40mm, and 45mm. The 10.0mm bone screws will be available in one standard version only in lengths from 35mm to 60mm in increments of 5mm.
1
Intended Use:
The following are specific indications for the Osteonics® Spinal System:
For non-pedicular fixation of the T4-S2 spine:
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis) .
- Vetebral fracture or dislocation .
- . Spinal stenosis
- Spondylolisthesis .
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by patient history and radiographic studies).
- Previously failed fusion .
- Spinal tumor .
For pedicular use:
- Additionally, when used as a pedicle screw system, the system is intended for patients: (a) . having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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. Pedicle screws are not intended for placement in pedicles above L3.
Statement of Technological Comparison:
The substantial equivalence of the Osteonics® Spinal System 5.5mm and 10.0mm bone screws to the predicate bone screws in the Osteonics® Spinal System, and for the 5.5mm bone screws, the Danek TSRH Spinal System and AcroMed Titanium Bone Screws, in terms of intended use and design features, is based on the following:
Intended Uses:
The intended uses of the subject devices are substantially equivalent to those of the predicate devices.
Material:
The Osteonics® Spinal System and the AcroMed Titanium Bone Screws are manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI). The Danek TSRH Spinal System is manufactured from ASTM F-138-92 Stainless Steel alloy.
Design:
The design and function of the subject spinal system bone screws remains unchanged and is substantially equivalent to that of the predicate bone screws.
Summary
Based on the similarities presented above and the supporting testing summary, the substantial equivalence of the Osteonics® Spinal System to the bone screws of the legally marketed Osteonics® Spinal System, Danek TSHR Spinal System, and AcroMed Titanium Bone Screws is demonstrated.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized depiction of three human profiles facing right, arranged in a row. The profiles are black and have a flowing, abstract design. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUM. SERVICES • USA" in a circular arrangement.
SEP 2 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kate Sutton Regulatory Affairs Specialist OSTEONICS Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re : K983152 5.5mm and 10.0mm Bone Screws to be used with the Osteonics® Spinal System Requlatory Class: II Product Codes: MNH and KWP Dated: September 1, 1998 Received: September 9, 1998
Dear Ms. Sutton:
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 (Act). This decision is based on your device system being 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.
3
Page 2 - Ms. Kate Sutton
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval. (PMA) application prior to marketing. Accordinqly:
- 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 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 not label or in anyway promote this device system 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.
4
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 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) requlations 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 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 Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq 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.
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.
5
Page 4 - Ms. Kate Sutton
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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,
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
6
510(k) Number (if known): K 983152
Device Name: Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws
Indications For Use:
The uses for the Osteonics® Spinal System 5.5mm & 10.0mm Bone Screws, as part of the legally marketed Osteonics® Spinal System, are as follows:
Non-Pedicular Use; fixation of the T4-S2 spine:
- Long and short curve scoliosis .
- . Vetebral fracture or dislocation
- t Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of . the disc confirmed by history and radiographic studies).
- D Previously failed fusion
- Spinal tumor
Pedicular Use:
- の When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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. Pedicle screws are not intended for placement in pedicles above L3.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General Restorative Devices 510(k) Number K983/So
OR
Prescription Use
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)