(7 days)
The TIMX Spine System is 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 TIMX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The TIMX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The CrossOver Cross Connector is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement.
The provided text is a 510(k) summary for the TIMX Spine System, specifically mentioning the CrossOver Cross Connector. It describes the device, its intended use, and materials. It also states that "Performance data were submitted to characterize the CrossOver Cross Connector." However, the document does not provide details about specific acceptance criteria, the study design, or the results of any performance studies in a way that would allow filling out the requested table or answering the specific questions about sample sizes, ground truth establishment, or expert involvement.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance studies.
- The type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document only broadly states that "Performance data were submitted to characterize the CrossOver Cross Connector." Without access to those submitted performance data, it is impossible to answer the specific questions posed.
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510(k) Summary
| SUBMITTER: | DePuy AcroMed, Inc.325 Paramount DriveRaynham, MA 02780 |
|---|---|
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | August 28, 2001 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | TIMX Spine System |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector(K983583)EZ-Link Transverse Connector (K001372, K001470) |
| DEVICE DESCRIPTION: | The CrossOver Cross Connector is designed totransversely connect two rods used in spinalinstrumentation constructs. The connector minimizesthe torsional forces on the construct, thus reducingthe micromotion and the probability of the constructshifting after placement. |
| INTENDED USE: | The TIMX Spine System is a pedicle screw systemintended to provide immobilization and stabilization ofspinal segments in skeletally mature patients as anadjunct to fusion in the treatment of the followingacute and chronic instabilities or deformities of thethoracic, lumbar, and sacral spine: degenerativespondylolisthesis with objective evidence ofneurological impairment, fracture, dislocation,scoliosis, kyphosis, spinal tumor, and failed previousfusion (pseudarthrosis).The TIMX Spine System is also indicated for pediclescrew fixation for the treatment of severespondylolisthesis (Grades 3 and 4) of the L5-S1vertebra in skeletally mature patients receiving fusionby autogenous bone graft having implants attached tothe lumbar and sacral spine (L3 to sacrum) withremoval of the implants after the attainment of a solidfusion. |
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The TIMX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), turnor, and previous failed fusion (pseudarthrosis).
| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium alloy. |
|---|---|
| PERFORMANCE DATA: | Performance data were submitted to characterize t |
Performance data were submitted to characterize the CrossOver Cross Connector.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers inside of a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 92001
Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K013295
Trade/Device Name: TiMX Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Code: MNH, MNI, KWP Dated: October 2, 2001 Received: October 2, 2001
Dear Mr. Maas:
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 encerdance 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, controlis provisions or actice, 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 0991 for submit 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 moportions 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.
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Page 2 - Mr. Frank Maas
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 nredicate 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, (201) 59 + 103 + 103 + 103 + 1 + 1 + 1 + 1 + 1 + 1 + 1 + 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 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,
Luse Walter, us
Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive lowercase letter, possibly an 'f' or a stylized 'l', connected to a wavy line. The symbol is drawn in black ink on a white background, and the overall impression is simple and abstract.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
TIMX Spinal System Device Name:
Indications For Use:
The TIMX Spine System is 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 TIMX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The TIMX Spine System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scollosis, lordosis and/or kyphosis), turnor, and previous failed 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:
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013295
N/A