(16 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "Osteonics® Spinal System" intended for fixation of the spine to address various spinal conditions, including deformities, fractures, stenosis, spondylolisthesis, degenerative disc disease, and previously failed fusions. These are all conditions that would require therapeutic intervention.
No
This device is described as an Osteonics® Spinal System, which is a system of bone screws and parts used for surgical implantation to provide spinal fixation and aid in successful fusions in the spine. It is a treatment device, not a diagnostic one.
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)" and describes physical components like "bone screws." This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states the Osteonics® Spinal System is comprised of "single-use, non-sterile devices manufactured from ASTM F-136-96 Titanium Alloy (Ti6Al-4V ELI)." It describes bone screws and their configurations.
- Intended Use: The intended use is for "non-pedicular fixation of the T4-S2 spine" and "pedicular use" for spinal conditions like deformities, fractures, stenosis, spondylolisthesis, degenerative disc disease, failed fusion, and tumors. This involves surgically implanting devices to stabilize the spine.
The device is a surgical implant used for structural support and fixation within the body, not for testing biological samples outside the body.
N/A
Intended Use / Indications for 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) .
- . Vertebral 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.
The uses for the legally marketed Osteonics® Spinal System are as follows:
Non-Pedicular Use; fixation of the T4-S2 spine:
- 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
Pédicular Use:
- 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
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 cylindrical bone screws will be available in standard and extra-long versions in lengths and diameters identical to the predicate top loading tapered screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T4-S2 spine, L5-S1 joint, lumbar and sacral spine
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)
Reference Device(s)
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
Special 510(k) Premarket Notification
1 1 8 1498
510(k) Premarket Notification Summary of Safety and Effectiveness for the
Osteonics® Spinal System Cylindrical Bone Screws
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Date of Summary Preparation:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Kate Sutton Regulatory Affairs Specialist
November 30, 1998
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Osteonics® Spinal System Cylindrical Bone Screws
Spinal fixation appliance
Spinal Interlaminal Fixation Orthosis 21 CFR 8888.3050
Predicate Device Identification
The Osteonics® Spinal System, which includes bone screws, was determined to be substantially equivalent via 510(k) #K951725. The proposed cylindrical bone screws of the Osteonics® Spinal System are substantially equivalent to the tapered bone screws in the Osteonics® Spinal System.
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 cylindrical bone screws will be available in standard and extra-long versions in lengths and diameters identical to the predicate top loading tapered screws.
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) .
- . Vertebral 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 cylindrical bone screws to the predicate bone screws in the Osteonics® Spinal System, in terms of intended use and design features, is based on the following:
Intended Uses:
The intended uses of the subject bone screws are identical to those of the predicate bone screws.
Material:
The Osteonics® Spinal System is manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI).
Design:
The design of the modified cvlindrical bone screw differs from the predicate bone screw in that the modified bone screw distal diameter is the same as the proximal diameter. The function of the modified spinal system bone screws remains unchanged and is identical to that of the predicate Danek TSRH bone screws.
Summary
Based on the similarities presented above and the supporting analyses, the substantial equivalence of the subject cylindrical bone screws to the predicate tapered bone screws of the legally marketed Osteonics® Spinal System is demonstrated.
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 representation of a human figure in profile, with three overlapping silhouettes suggesting a sense of community and support. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1998
Ms. Kate Sutton Regulatory Affairs Specialist Stryker Osteonics® 59 Route 17 Allendale, New Jersey 07401-1677
Re: K984302
Cylindrical Bone Screws - part of the Osteonics® Spinal System Regulatory Class: II Product Codes: MNH and KWP Dated: November 30, 1998 Received: December 2, 1998
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 (OS) 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 vours.
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
4
510(k) Number (if known): K984-302
Device Name: Osteonics® Spinal System
Indications For Use:
The uses for the legally marketed Osteonics® Spinal System are as follows:
Non-Pedicular Use; fixation of the T4-S2 spine:
- 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
Pédicular Use:
- 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 (C
coll
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number_ K984302
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)