(141 days)
Not Found
Not Found
No
The summary describes a mechanical spinal fixation system composed of various metal components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a spinal fixation system intended to treat various spinal conditions, including degenerative disc disease, fractures, and deformities, which are therapeutic interventions.
No
The DYNA-LOK PLUS™ Spinal System is a spinal fixation system, meaning it is a device used to stabilize or correct the spine during surgical procedures. Its intended use and device description clearly define it as an implantable medical device for treatment, not for diagnosing conditions.
No
The device description explicitly lists various physical components made of stainless steel or titanium alloy, such as rods, bolts, plates, and screws, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly indicate that the DYNA-LOK PLUS™ Spinal System is a physical implant used for spinal fixation in skeletally mature patients with various spinal conditions. It is surgically implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, providing diagnostic information based on laboratory tests, or any other activity associated with in vitro diagnostics.
The device is a surgical implant used for structural support and stabilization of the spine.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK PLUS™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is also indicated for skeletally mature 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 (1.3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used for posterior, non-pedicle screw fixation, the DYNA-LOK PLUS™ Spinal system is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.
When used as an anterolateral thoracic/lumbar system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
Product codes
KWP, KWQ, MNH, MNI
Device Description
The DYNA-LOK PLUS™ Spinal System consists of a variety of shapes and sizes of rods, bolts, plates, screws, clamps, connectors, cross-connectors, washers and nuts. The DYNA-LOK PLUS™ Spinal System may be used with TSRH® Hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates and/or MULTI-AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates. The DYNA-LOK PLUS™ Spinal System bolts and rod/bolt connectors may be used in conjunction with GDLH™ Spinal System rods, TSRH® Spinal System rods, TENOR™ Spinal System rods and CD® HORIZON Spinal System rods and their respective system indications. These components are assembled to fit the patient's anatomic specific needs. Instrumentation is also available to facilitate implantation of the device components.
DYNA-LOK PLUS™ Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3. These implants may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Non-cervical posterior spine, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 and below), thoracic, lumbar, and sacral (T1 - Sacrum)
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)
Mechanical testing data were provided or referenced to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
AUG 2 / પિકને
DYNA-LOK PLUSTM Spinal System -Summary of Safety and Effectivenes May 26, 1999
- Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Proposed Proprietary Trade Name: DYNA-LOK PLUSTM Spinal System 【】.
Product Description III.
The DYNA-LOK PLUS™ Spinal System consists of a variety of shapes and sizes of rods, bolts, plates, screws, clamps, connectors, cross-connectors, washers and nuts. The DYNA-LOK PLUS™ Spinal System may be used with TSRH® Hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates and/or MULTI-AXIAL Low Profile MULTI-SPAN™ CROSSLINK® plates. The DYNA-LOK PLUS™ Spinal System bolts and rod/bolt connectors may be used in conjunction with GDLH™ Spinal System rods, TSRH® Spinal System rods, TENOR™ Spinal System rods and CD® HORIZON Spinal System rods and their respective system indications. These components are assembled to fit the patient's anatomic specific needs. Instrumentation is also available to facilitate implantation of the device components.
DYNA-LOK PLUS™ Spinal System implant components are fabricated from stainless steel conforming to ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the implant components may be manufactured from titanium alloy conforming to ASTM F-136 titanium alloy, or ISO 5832-3. These implants may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implants in a spinal construct.
IV. Indications
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK PLUS™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is also indicated for skeletally mature 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 (1.3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
1
When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used for posterior, non-pedicle screw fixation, the DYNA-LOK PLUS™ Spinal system is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.
When used as an anterolateral thoracic/lumbar system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
V. Substantial Equivalence
The DYNA-LOK PLUS™ Spinal System is substantially equivalent to other legally marketed devices. Mechanical testing data were provided or referenced to demonstrate substantial equivalence.
© 1999 Sofamor Danek. All rights reserved.
2
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
AUG 27 19999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Richard W. Treharne Vice President, Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K991198
Trade Name: DYNA-LOK PLUS Spinal System Regulatory Class: II Product Code: KWP, KWQ, MNH and MNI Dated: July 8, 1999 Received: July 9, 1999
Dear Dr. Treharne:
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 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 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.
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.
3
Page 2 - Dr. Richard W. Treharne
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,
Thurell J. Hager
ダン〜 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): K991198
DYNA-LOK PLUS™ Spinal System Device Name: Indications for Use:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK PLUS™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
- In addition, when used as a pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst sacral (LS-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 (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used for posterior, non-pedicle screw fixation, the DYNA-LOK PLUS™ Spinal system is intended for thoracic, lumbar, and sacral (T1 - Sacrum) fixation only.
When used as an anterolateral thoracic/lumbar system, the DYNA-LOK PLUS™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)
OR Over-the-counter Use __
Junell P. Payne Sartin
(Division Sign-Off) Division of General Restorative Device 510(k) Number