MONARCH SPINE SYSTEM

K021335 · Depuyacromed · MNH · Jul 11, 2002 · Orthopedic

Device Facts

• Record ID: K021335
• Device Name: MONARCH SPINE SYSTEM
• Applicant: Depuyacromed
• Product Code: MNH · Orthopedic
• Decision Date: Jul 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodvlolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum. The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire. and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor. fracture and previous failed fusion.

Device Story

Spinal fixation system comprising pedicle screws, washers, plates, rods, connectors, hooks, and nuts; provides stabilization for thoracic, lumbar, and sacral spine. Used by surgeons in clinical settings to treat degenerative conditions, deformities, and fractures. Device components implanted to provide structural support during fusion process; pedicle screws for Grade 3/4 spondylolisthesis intended for removal post-fusion. System provides mechanical stabilization to facilitate bone healing and patient recovery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manufactured from ASTM F-136 implant grade titanium alloy or ASTM F-76 commercially pure titanium. System includes pedicle screws, washers, plates, rods, connectors, and hooks. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients with degenerative disc disease, spondylolisthesis, spinal deformities (scoliosis, lordosis, kyphosis), spinal tumors, fractures, or failed previous fusion. Fixation levels include thoracic, lumbar, and sacral spine. Grade 3/4 spondylolisthesis at L5-S1 requires skeletally mature patients and autologous bone graft.

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

• ISOLA Spinal System (K993030)
• Tri-Fix Spinal Fixation System (K011830)

Submission Summary (Full Text)

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## JUL 11 2002 510(k) Summary XIII. DePuy AcroMed, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780 Lisa A. Gilman CONTACT PERSON: DATE PREPARED: April 18, 2002 CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis PROPRIETARY NAME: MONARCH Spine System PREDICATE DEVICES: ISOLA Spinal System (K993030) Tri-Fix Spinal Fixation System (K011830) The MONARCH Spine System consists of pedicle DESCRIPTION: screws, washers, spine plates, spinal rods, slotted connectors, dual rod connectors, J-hooks, polyaxial screws, open hooks, closed hooks, and spherical nuts. The MONARCH Spine System when used with INTENDED USE: pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodvlolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis,

spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

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The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire. and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor. fracture and previous failed fusion.

Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy or ASTM F-76 commercially pure titanium.

PERFORMANCE DATA:

Performance data were submitted to characterize the MONARCH Spine System.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 11 2002

Mr. Frank Maas Director, Regulatory Affairs Depuv AcroMed 325 Paramount Drive Raynham, MA 02767-0350

Re: K021335

> Trade Name: MONARCH Spine System Regulation Number: 21 CFR 888.3050 and 888.3070 Regulation Name: Pedicle Screw Spinal System, and Spinal Interlaminal Fixation Orthosis Regulatory Class: III, II Product Code: MNH, MNI, KWP Dated: April 19, 2002 Received: April 26, 2002

Dear Mr. Maas:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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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 needicate 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,

Stupt Rlwdus

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 IV. :

:510(k) Number (if known): __ 上 ○ 乙 : 3 3 S

MONARCH Spine System Device Name:

Indications For Use:

The MONARCH Spine System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodvlolisthesis with objective evidence of neurologic impairment. fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis and kyphosis), tumor, fracture and previous failed fusion.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-------------------------------------------|--------------------------------------------------------------|--------|
| Prescription Use:<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use: | |
| DePuy AcroMed, Inc.<br>510K | Division of General, Restorative<br>and Neurological Devices | Page 6 |
| | KOZI335<br>510(k) Number_ | |