MOSS MIAMI SPINAL SYSTEMS

K013296 · Depuyacromed · MNH · Oct 9, 2001 · Orthopedic

Device Facts

• Record ID: K013296
• Device Name: MOSS MIAMI 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 Moss Miami 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 Moss Miami 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 Moss Miami Spine System is also a hook and sacral/illiac 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 (pseudanthrosis).

Device Story

Moss Miami Spine System is a spinal instrumentation construct comprising pedicle screws, hooks, and sacral/iliac screws; includes CrossOver Cross Connector for transverse rod connection. Device used by surgeons in clinical settings to stabilize spinal segments. Connector minimizes torsional forces, reducing construct micromotion and shifting. System provides rigid fixation to facilitate fusion in patients with spinal deformities or instabilities. Benefits include improved construct stability and reduced risk of hardware failure during the fusion process.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Manufactured from ASTM F-136 implant-grade titanium alloy. System consists of pedicle screws, hooks, sacral/iliac screws, and transverse connectors. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats thoracic, lumbar, and sacral spine instabilities/deformities including degenerative spondylolisthesis, fractures, dislocations, scoliosis, kyphosis, spinal tumors, pseudarthrosis, degenerative disc disease, and spinal stenosis. Includes specific indication for L5-S1 Grade 3-4 spondylolisthesis with autogenous 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

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

Submission Summary (Full Text)

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K013296

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## 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: | Moss Miami 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 Moss Miami Spine System is a pedicle screw<br>system intended to provide immobilization and<br>stabilization of spinal segments in skeletally mature<br>patients as an adjunct to fusion in the treatment of the<br>following acute and chronic instabilities or deformities<br>of the thoracic, lumbar, and sacral spine:<br>degenerative spondylolisthesis with objective<br>evidence of neurological impairment, fracture,<br>dislocation, scoliosis, kyphosis, spinal tumor, and<br>failed previous fusion (pseudarthrosis).<br><br>The Moss Miami 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 |

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The Moss Miami Spine System is also a hook and sacral/illiac 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 (pseudanthrosis).

Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.

PERFORMANCE DATA:

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 features a stylized symbol resembling an abstract bird or wing design, composed of three curved lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2001

Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

K013296 Re:

Trade/Device Name: Moss Miami Spinal System Trade/Device Name: Moss Max.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 teviewed your became or 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 encreasary to active Amendments, or to devices that have been reclassified in enacificin cate of the Medical Dorter Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the devices casyone to equirements for annual registration, listing of devices, Controls provisions of the receiners 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 (1 childing 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 099. It substannally of 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 Inspections, the Food and Drag realiting action. In addition, FDA may publish comply with the GMT Togalaxis 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 noutheation. The I Driving of easification 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 If you desire specific acvices in the subscric devices), please contact the Office of Compliance at additionally 607.10 for in True allestions on the promotion and advertising of your device, [phone]. prease conding 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 mionitation on your responsionate and more [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Walker, MD

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character that appears to be a stylized letter or signature. It features a curved line at the top, resembling a loop, connected to a shorter, horizontal stroke at the bottom right. The overall impression is that of a quick, fluid stroke, possibly representing the initials or a unique mark of an individual.

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): ____________________________________________________________________________________________________________________________________________________

Moss Miami Spinal System Device Name:

Indications For Use:

The Moss Miami Spine System is a pedicle screw system intended to provide i ne Moss Miami Opine System is spinal segments in skeletally mature patients immobilization and Studilization of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative instablimes or deformiato of the evidence of neurological impairment, fracture, dislocation, scollosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spine System is also indicated for pedicle screw fixation for the The Moss Miami of severe sponding sis (Grades 3 and 4) of the L5-S1 vertebra in treathern of sover or sevents 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 Moss Miami Spine System is also a hook and sacral/iliac screw fixation The Moss Miam Opinical spine indicated for degenerative disc disease (defined as system of the norformeration of the disc confirmed by history and ulslogenic back pain with dogolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, 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: > (Per 21 CFR 801.109)

OR Over-The-Counter Use: _____________________________________________________________________________________________________________________________________________________

SL

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

510(k) Number k013296