(84 days)
The VERSALOK Low Back Fixation System is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature.
- A construct with screws attached to the pedicles of the lumbar and sacral spine (1,3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (grade 3 or 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warning below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
- When not used as a pedicle screw fixation system, various combinations of the VERSALOK components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
a) Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
b) Degenerative disk diseases of the spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
c) Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
Progressive, despite other forms of treatment,
Detrimental to cardiopulmonary function,
Interfering with spinal mechanics or causing severe back pain, or
Cosmetically unacceptable, progressive, and painful.
For the above indications, use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity. - The VERSALOK Low Back Fixation System is also a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The VERSALOK is a posterior spinal fixation system consisting of various types and sizes of implantable components (screws, rods, couplers, etc.) that are assembled to create a spinal construct. It features a low profile as well as a top loading design. The VERSALOK is offered for sale both in stainless steel and titanium.
The VERSALOK Low Back Fixation System underwent mechanical testing to demonstrate its performance characteristics.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance characteristics (bending-compression static stiffness, torsional stiffness, and fatigue strength) | Comparable to those of predicate devices |
2. Sample Size and Data Provenance for Test Set:
The document does not explicitly state the sample size used for the mechanical testing. The data provenance is not specified beyond indicating it was performed by Osteotech, Inc.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable as the study involved mechanical testing of a physical device, not an expert-driven assessment.
4. Adjudication Method for Test Set:
Not applicable for mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted as this is a mechanical device, not typically requiring such a study.
6. Standalone Performance (Algorithm Only):
Not applicable, as this is a physical medical device and not an AI algorithm.
7. Type of Ground Truth Used:
The ground truth was established through mechanical testing of the VERSALOK constructs against established ASTM standards and in comparison to predicate devices.
8. Sample Size for Training Set:
Not applicable, as the document refers to post-market mechanical testing for device performance comparison, not a training set for an algorithm.
9. How Ground Truth for Training Set Was Established:
Not applicable.
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510(k) Submission for VERSALOK
Osteotech, Inc.
NOV 1 9 1999
510(k) Summary of Safety and Effectiveness VIII.
Nov. 16, 1999
- Submission Applicant & Correspondent:
| Name: | Osteotech, Inc. |
|---|---|
| Address: | 51 James Way |
| Eatontown, NJ 07724 | |
| Phone No.: | (732) 542-2800 |
| Contact Person: | Jing Zhang |
-
- Name of Device: Trade/Proprietary/Model Name: Versalok® Low Back Fixation System (VERSALOK) Posterior Spinal Fixation Device Common or Usual Name: Spinal Interlaminal Fixation Orthosis; Classification Names: Spondylolisthesis Spinal Fixation Device System: Pedicle Screw Spinal System
-
- Devices to Which New Device is Substantially Equivalent: The VERSALOK is substantially equivalent, for the purpose of this 510(k) adding indications, to the following predicate devices.
| Trade/Proprietary/Model Name | Manufacturer |
|---|---|
| VERSALOK | Wright Medical Technology, Inc. |
| SSCS | Ulrich GmbH & Co. KG |
| ISOLA Spinal System | DePuy AcroMed, Inc. |
4. Device Description:
The VERSALOK is a posterior spinal fixation system consisting of various types and sizes of implantable components (screws, rods, couplers, etc.) that are assembled to create a spinal construct. It features a low profile as well as a top loading design. The VERSALOK is offered for sale both in stainless steel and titanium.
- Intended Use/Indications
The VERSALOK Low Back Fixation System is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature.
-
- A construct with screws attached to the pedicles of the lumbar and sacral spine (1,3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (grade 3 or 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint (see warning
{1}------------------------------------------------
ech. Inc.
below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
-
- When not used as a pedicle screw fixation system, various combinations of the VERSALOK components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
- a) Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
- b) Degenerative disk diseases of the spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- c) Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
- Progressive, despite other forms of treatment, ●
- Detrimental to cardiopulmonary function, .
- Interfering with spinal mechanics or causing severe back pain, or ●
- Cosmetically unacceptable, progressive, and painful. t
For the above indications, use of spinal fixation instrumentation in children has been reported.1.2 Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
-
- The VERSALOK Low Back Fixation System is also a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
-
- Performance Data
Mechanical testing of VERSALOK constructs was performed in accordance with the ASTM Standard for testing spinal implant devices. The test results demonstrated that the mechanical performance characteristics (bending-compression static stiffness, torsional stiffness and fatigue strength) of VERSALOK construct are comparable to those of the predicate devices.
- 011
2 of 2
1. Heftl, F.L. and McMaster, J.J .: The Effect of the Adolescent Growth Spurt on Early Posterior Spinal Fusion in Infantile and Juvenile Idiopathic Scoliosis. J. Bone and Joint Surg. 1983;65-B:247-254.
2. Moe, J.H., Kharrat, K., et al .: Harrington Instrumentation Without Fusion Plus External Orthotic Support the Treatment of Difficult Curvature Problems in Young Children. Clin. Ortho. Rel. Res. 1984; (185):35-45.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Ms. Jing Zhang Requlatory Affairs Specialist Osteotech, Inc. 51 James Way 07724 Eatontown, New Jersey
Re: K992885 Trade Name: VERSALOK™ Low Back Fixation System Regulatory Class: II Product Codes: KWP, MNI, and MNH Dated: August 26, 1999 Received: August 27, 1999
Dear Ms. Zhang:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation 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 requlations.
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Page 2 - Ms. Jing Zhang
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" (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden
James E. Dillard III for
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Submission for VERSALOK - Additional Indications
VERSALOK - Additional Indications
L. Indications for Use Statement:
510(k) Number (if known): K992885 Device Name: Versalok® Low Back Fixation System
Indications for Use:
The VERSALOK Low Back Fixation System is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature.
-
- A construct with screws attached to the pedicles of the lumbar and sacral spine (13 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (grade 3 or 4) at the fifth lumbar - first sacral (LS-S1) vertebral joint (see warning below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
-
- When not used as a pedicle screw fixation system, various combinations of the VERSALOK components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (TI to S1) during bony fusion healing secondary to:
- a) Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
- b) Degenerative disk diseases of the spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- c) Spinal curvatures (such as idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
- Progressive, despite other forms of treatment, .
- Detrimental to cardiopulmonary function, ●
- Interfering with spinal mechanics or causing severe back pain, or
- Cosmetically unacceptable, progressive, and painful. .
For the above indications, use of spinal fixation instrumentation in children has been reported.1-2 Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
-
- The VERSALOK Low Back Fixation System is also a pedicle screw system 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
1 4, 2
- The VERSALOK Low Back Fixation System is also a pedicle screw system 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
Osteotech. Inc.
ﻨﺴ Heftl, F.L. and McMaster, J.J.: The Effect of the Adolescent Growth Spurt on Early Posterior Spinal Fusion in Infantile and Juvenile Idiopathic Scoliosis. J. Bone and Joint Surg. 1983;65-B:247-254.
2. Moe, J.H., Kharrat, K., et al.: Harrington Instrumentation Without Fusion Plus External Orthotic Support the Treatment of Difficult Curvature Problems in Young Children. Clin. Ortho. Rel. Res. 1984; (185):35-45.
{5}------------------------------------------------
510(k) Submission for VERSALOK - Additional Indications
deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Tho for
(Division Sign-Off)
Division of General Restorative Devices K992885
510(k) Number
2012
N/A