(7 days)
The Monarch 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 Monarch 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 Monarch 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.
I am sorry, but the provided text from K013294 does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets them.
The document is a 510(k) summary for a spinal system and primarily focuses on the device description, intended use, and substantial equivalence to predicate devices. While "Performance data were submitted to characterize the CrossOver Cross Connector" is mentioned, the specific criteria, the study design, results, or any of the other requested details are not included in this summary.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case comparative effectiveness study or effect size.
- Information about a standalone performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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OCT - 9 2001
510(k) Summary
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| 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: | Monarch 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 Monarch 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 Monarch Spine System is also indicated forpedicle screw 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. |
| The Monarch 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). | |
| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium alloy. |
| PERFORMANCE DATA: | Performance data were submitted to characterize the CrossOver Cross Connector. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird in flight, composed of three curved lines.
OCT - 92001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
K013294 Re:
Trade/Device Name: Monarch Spinal System Trade Doviet Name: 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 we have neviewed your becaon 910(x) its substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the Stated in the energoure) to device Amendments, or to devices that have been reclassified in enacificin date of the Modical Dortes Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the general controls provisions of the Act. The general therefore, marker the device, easyone equirements for annual registration, listing of devices, Controls provisions or the receive, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see accurie) t to such additional controls. Existing major regulations (1 remarket Approval), it the J of Eagle of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good 675. A substantially equirement, 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 mspections, the Food and Drag in may result in regulatory action. In addition, FDA may publish comply with and Crici regular device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premation is 22 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 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Sus. Wal., MD
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
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Indications for Use
Indications for Use
510(k) Number (if known): K013294
Monarch Spinal System Device Name:
Indications For Use:
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The Monarch Spine System is also indicated for pedicle screw fixation for the The Monarch Opine Oyelom to dios in (Grades 3 and 4) of the L5-S1 vertebra in treatment of sovers openay.com/ving fusion by autogenous bone graft having skeletally mature pations roosing is a sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Monarch Spine System is also a hook and sacral/iliac screw fixation system of The Monarch Optic Oyotential talled for degenerative disc disease (defined as the noncer near spirie with degeneration of the disc confirmed by history and discogence back pain with dogeneress, trauma (fracture and/or dislocation), spinal radiographic studios), spoliosis, lordosis and/or kyphosis), tumor, 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: Just OR Over-The-Counter Use: _____________________________________________________________________________________________________________________________________________________ (Pcr 21 CFR 801.109)
Division Sign-Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013294
N/A