MONARCH SPINAL SYSTEMS

K013294 · Depuyacromed · MNH · Oct 9, 2001 · Orthopedic

Device Facts

• Record ID: K013294
• Device Name: MONARCH SPINAL SYSTEMS
• Applicant: Depuyacromed
• Product Code: MNH · Orthopedic
• Decision Date: Oct 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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).

Device Story

Monarch Spine System is a pedicle screw, hook, and sacral/iliac screw fixation system; includes CrossOver Cross Connector for transverse rod connection. Device minimizes torsional forces on spinal constructs; reduces micromotion and construct shifting post-placement. Used in surgical settings by orthopedic or neurosurgeons to stabilize spinal segments during fusion procedures. Provides mechanical immobilization to facilitate bone fusion in patients with spinal deformities or instabilities. Benefits include improved structural stability of the spine during the healing process.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manufactured from ASTM F-136 implant grade titanium alloy. Mechanical fixation system consisting of pedicle screws, hooks, and transverse connectors. Standalone mechanical device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for acute/chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, severe L5-S1 spondylolisthesis (Grades 3-4), degenerative disc disease, and spinal stenosis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MOSS MIAMI Spinal System Transverse Connector (K983583)
• EZ-Link Transverse Connector (K001372, K001470)

Submission Summary (Full Text)

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K013294

OCT - 9 2001

## 510(k) Summary

.

| SUBMITTER: | DePuy AcroMed, Inc.<br>325 Paramount Drive<br>Raynham, MA 02780 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | August 28, 2001 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal<br>Orthosis, Spinal Pedicle Fixation |
| PROPRIETARY NAME: | Monarch Spine System |
| PREDICATE DEVICES: | MOSS MIAMI Spinal System Transverse Connector<br>(K983583)<br>EZ-Link Transverse Connector (K001372, K001470) |
| DEVICE DESCRIPTION: | The CrossOver Cross Connector is designed to<br>transversely connect two rods used in spinal<br>instrumentation constructs. The connector minimizes<br>the torsional forces on the construct, thus reducing<br>the micromotion and the probability of the construct<br>shifting after placement. |
| INTENDED USE: | The Monarch Spine System is a pedicle screw system<br>intended to provide immobilization and stabilization of<br>spinal segments in skeletally mature patients as an<br>adjunct to fusion in the treatment of the following<br>acute and chronic instabilities or deformities of the<br>thoracic, lumbar, and sacral spine: degenerative<br>spondylolisthesis with objective evidence of<br>neurological impairment, fracture, dislocation,<br>scoliosis, kyphosis, spinal tumor, and failed previous<br>fusion (pseudarthrosis).<br>The Monarch Spine System is also indicated for<br>pedicle screw fixation for the treatment of severe<br>spondylolisthesis (Grades 3 and 4) of the L5-S1<br>vertebra in skeletally mature patients receiving fusion<br>by autogenous bone graft having implants attached to<br>the lumbar and sacral spine (L3 to sacrum) with<br>removal of the implants after the attainment of a solid<br>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). |
| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone], 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:

The Monarch Spine System is a pedicle screw system intended to provide The Monarch Spine Oystem is a psinal segments in skeletally mature patients if in lobilization and stablicationship. of the following acute and chronic as an adjunct to idsion in the trounds of the tellowid sacral spines of arman Instablifies or deformides or the thirds, of neurological impairment, fracture, spondylolistinesis with objectis, spinal tumor, and failed previous fusion (pseudarthrosis).

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)

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(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013294