(13 days)
Not Found
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for various spinal conditions such as scoliosis, vertebral fracture, spondylolisthesis, and degenerative disc disease, which are therapeutic interventions aimed at treating or alleviating these conditions.
No
The device description and intended use/indications for use describe the Osteonics® Spinal System as an implantable system for spinal fusion and stabilization, treating various spinal conditions. It does not mention any diagnostic capabilities or functions.
No
The device description clearly describes a physical implantable device (Combination Screw Ring/Blocker) used in spinal surgery, not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the spine in various conditions like scoliosis, fractures, and spondylolisthesis. This is a therapeutic device used in vivo (within the body).
- Device Description: The device description details a mechanical component (screw ring/blocker) designed for surgical implantation and fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, and KWP
Device Description
The Combination Screw Ring/Blocker incorporates the blocker into the design of the containment ring, resulting in a single, preassembled component. The blocker portion of the Combination Screw Ring/Blocker is preassembled in the factory to the containment ring via a snap-fit assembly process. The proximal portion of the existing Screw Blocker has been modified to include a proximal circular "lip". Two bars on the proximal side of the containment ring expand and retract to allow the snap-fit insertion of the proximal lip of the blocker component. The locking mechanism and function of the Combination Screw Ring/Blocker is identical to that currently employed by the Long Arm Containment Ring and the Screw Blocker. The Combination Screw Ring Blocker is placed over the screw arms. The blocker is then tightened, which expands the proximal portion of the screw creating a friction-fit lock between the proximal screw and the containment ring portion of the Combination Screw Ring/Blocker. The screw arms are then broken off.
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
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
Osteonics® Combination Ring/Blocker
510(k) Premarket Notification
то
FEB 1 . 1999
510(k) Premarket Notification Summary of Safety and Effectiveness for the
1990158
Osteonics® Combination Screw Ring/Blocker (A Component of the Osteonics® Spinal System)
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677
Marybeth Naughton Regulatory Affairs Team Member
January 20, 1999
Osteonics® Combination Screw Ring/Blocker
Spinal fixation appliance
Spinal Interlaminal Fixation Orthosis 21 CFR §888.3050 Pedicle Screw System 21 CFR 8888.3070
Predicate Device Identification
The Osteonics® Long Arm Containment Ring, a component of the Osteonics® Spinal System, was determined to be substantially equivalent via 5109k) #K981452. The Osteonics® Spinal System Screw Blocker was determined to be substantially equivalent via 5109k) #K951725. The proposed Osteonics® Combination Screw Ring/Blocker is substantially equivalent to the Osteonics® Long Arm Containment Ring and Osteonics® Spinal System Screw Blocker.
Device Description
The Combination Screw Ring/Blocker incorporates the blocker into the design of the containment ring, resulting in a single, preassembled component. The blocker portion of the Combination Screw Ring/Blocker is preassembled in the factory to the containment ring via a snap-fit assembly process. The proximal portion of the existing Screw Blocker has been modified to include a proximal circular "lip". Two bars on the proximal side of the containment ring expand and retract to allow the snap-fit insertion of the proximal lip of the blocker component.
1
Osteonics® Combination Ring/Blocker
510(k) Premarket Notification
TO
The locking mechanism and function of the Combination Screw Ring/Blocker is identical to that currently employed by the Long Arm Containment Ring and the Screw Blocker. The Combination Screw Ring Blocker is placed over the screw arms. The blocker is then tightened, which expands the proximal portion of the screw creating a friction-fit lock between the proximal screw and the containment ring portion of the Combination Screw Ring/Blocker. The screw arms are then broken off.
Intended 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 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.
Statement of Technological Comparison:
- The substantial equivalence of the Osteonics® Combination Screw Ring/Blocker, the predicate Long Arm Containment Ring and Screw Blocker of 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 and predicate devices are identical.
Material:
All components of the Osteonics® Spinal System are manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI).
2
Osteonics® Combination Ring/Blocker
510(k) Premarket Notification
TO
Design:
The subject Combination Screw Ring/Blocker incorporates the blocker into the design of the containment ring, resulting in a single, preassembled component. The blocker portion of the Combination Screw Ring/Blocker is preassembled in the factory to the containment ring via a snap-fit assembly process. The proximal portion of the predicate Screw Blocker has been modified to include a proximal circular "lip". Two parallel bars have been added to the proximal side of the predicate Long Arm Containment Ring. The bars expand and retract to allow the snap-fit insertion of the proximal lip of the blocker component. The function of the Combination Scrow Ring/Blocker is identical to that of the predicate Long Arm Containment Ring and Screw Blocker when used together.
Summary
Based on the similarities presented above and the supporting analyses, the substantial equivalence of the subject Combination Screw Ring/Blocker to the predicate Long Arm Containment Ring and Screw Blocker of the legally marketed Osteonics® Spinal System is demonstrated.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol representing the human form, depicted as three overlapping profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1999
Ms. Marybeth Naughton Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K990158
Osteonics® Spinal System - Combination Screw Ring/Blocker Regulatory Class: II Product Codes: MNI, MNH, and KWP Dated: January 12, 1999 Received: January 19, 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.
4
Page 2 - Ms. Marybeth Naughton
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,
Stupt Rhodes
An
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
5
Page 1 of 1
510(k) Number (if known): K990158
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 .
- 1 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.
(PLEASE DO NOT WRITE BELOW THIS IJNE-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 | K990158 |
|---|---|
| --------------- | --------- |
| Prescription Use X | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------------------------------------- | ---- | ------------------------------------------------------------------------ |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
|---|---|
| ---------------------- | -------------------------- |
Styph Plevels for CMU