MODIFICATION TO XIA SPINE SYSTEM

K012027 · Howmedica Osteonics · MNH · Jul 20, 2001 · Orthopedic

Device Facts

• Record ID: K012027
• Device Name: MODIFICATION TO XIA SPINE SYSTEM
• Applicant: Howmedica Osteonics
• Product Code: MNH · Orthopedic
• Decision Date: Jul 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 8.5mm diameter Xia Polyaxial Screws are intended to be used with the other components of the Xia Spine System.

Device Story

Xia Spine System 8.5mm diameter polyaxial screws are spinal fixation components used in noncervical spine surgery. Screws are manufactured from titanium alloy and feature a larger bone thread and tapered tip compared to the 7.5mm predicate. Device is implanted by surgeons to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Screws are used with other Xia Spine System components; closure screws secure the construct. Clinical benefit includes stabilization of spinal instabilities or deformities, facilitating solid fusion mass development. Device is intended for removal after fusion is achieved.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by engineering analysis and design comparison to the predicate device.

Technological Characteristics

Materials: Titanium alloy. Form factor: Polyaxial screw, 8.5mm diameter, 30-90mm lengths (5mm increments). Design: Tapered tip, threaded top for closure screw. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal stabilization. Used as pedicle screw fixation for severe spondylolisthesis (Grades 3-4 at L5-S1), degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and pseudarthrosis. Used as anterior or posterior hook/sacral/iliac screw fixation for degenerative disc disease (discogenic back pain confirmed by history/radiography), spinal stenosis, fracture, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or revision of failed fusion.

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

• Xia Polyaxial Screw (K984251)

Submission Summary (Full Text)

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# JUL 2 0 2001

K012027

**Special 510(k) Premarket Notification**

## Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Xia Spine System

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>59 Route 17<br>Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Ariemma<br>Regulatory Affairs Specialist |
| Date of Summary Preparation: | June 27, 2001 |
| <b>Device Identification</b> | |
| Proprietary Name: | Xia Spine System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis,<br>21 CFR 888.3050<br>Spinal Intervertebral Body Fixation Orthosis<br>21 CFR 888.3060<br>Pedicle Screw Spinal System |

#### Predicate Device Identification

The features of the 8.5mm diameter Xia Polyaxial Screw are substantially equivalent to the features of the predicate 7.5 mm diameter Xia Polyaxial Screw, which were determined substantially equivalent via 510(k) K984251.

21 CFR 888.3070

#### Device Description

The 8.5mm diameter Xia Polyaxial Screws are available in lengths ranging from 30 mm to 90 mm (in 5 mm increments). The top portion of the screw is threaded to accept a closure screw. The subject 8.5mm diameter Polyaxial Screw is identical to the 7.5 mm diameter Xia Polyaxial Screws except for the following differences: larger diameter bone thread and tapered screw tip. The subject screws are manufactured from titanium alloy.

#### Intended Use:

The 8.5mm diameter Xia Polyaxial Screws are intended to be used with the other components of the Xia Spine System.

#### Indications for Use:

The Xia Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

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When used as a pedicle screw fixation system, the XIA Spine System is also intended to provide When used as a pedicle screw illiation system, in skeletaly mature patients as an adjunct to
immobilization and stabilization of spinal segments in the or deformities of the immobilization and stabilization of sphial sogments instabilities of the spiective evidence of fusion in the treatment of the following acutive spondylolisthesis with objective evidence of
thoracic, lumbar, and sacral spine: degenerative spondylolishess wind tumor, and thoracic, lumbar, and sacral spille. degeneral. Fo spendy on the summer, and failed previous fusion (pseudarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/ilias screw
fix disc direct of the linet of the list of first at for restigate with dagementive When used as an anterior screw is indicated for patients with degenerative disc disease
fixation system, the XIA Spine System is indicated for partien of the disc confirmed b fixation system, the XIA Spine System is minded to: peacention of the disc confirmed by which is defined as back pain of uiscogene of an are somal seenosis, spinal seformities.
history and radiographic studies, spondylolisthesis, spinal sterosis, spinal sense history and radiographic siudies, spondylonistics, incours, spansion of failed fusion attempts.
such as scoliosis, kyphosis, tumor, pseudoarthrosis or revision of failed fusi

## Statement of Technological Comparison:

Statement of Lechnological Companisons
The 8.5 mm diameter Xia Polyaxial Screws share the Same diameter Xio Polyaxial Screws Ar The 8.5 mm diameter Xia Polyaxial Sciews Jahle 7.5 mm diameter Xia Polyaxial Screws. An
design concepts as that of the currently available 7.5 mm diameter Xia Polyaxial Stre design concepts as that of the currently available has and the subject 8.5mm diameter Xia
engineering analysis demonstrated the comparable properties of the subject 8.5mm di Polyaxial Screw to the predicate Xia Polyaxial Screws.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2001

Ms. Karen Ariemma Howmedica Osteonics Corp. Regulatory Affairs Specialist 59 Route 17 Allendale, New Jersey 07401

Re: K012027 Trade Name: Xia Spine System Regulatory Number: 888.3050, 888.3060, and 888.3070 Regulatory Class: II Product Code: MNH, KWP, KWQ, MNI Dated: June 27, 2001 Received: June 28, 2001

Dear Ms. Ariemma:

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 stated in the onerobare) to aceries Amendments, or to devices that have been reclassified in enacificin carity of the Frivaions 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 therefore, mainer the act requirements for annual registration, listing of devices, Controls provisions of the res, 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 ( remarket rippt vally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing 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 mspotions, the FMP 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.

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.

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### Page 2 - Ms. Karen Ariemma

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,

BMitchell Morton

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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510(k) Number (if known): KO(2○) /

Device Name: Xia Spine System

The 8.5mm diameter Xia Polyaxial Screws are intended to be used with the other components of the Xia Spine System.

Indications For Use:

The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw The XIA Opine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving (Grades 3 and +) at the first failfour - the reaving the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

When used as a pedicle screw fixation system, the XIA Spine System is also intended to provide when used as a podited becaments 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation which as a anterior System is indicated for patients with degenerative disc disease which is System, the All Popino of discogenic origin with degeneration of the disc confirmed by history and defined as back pain of also goteresis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
OR
Over-The-Counter Use (Per 21 CFR 801.109)
510(k) Number
(Optional Format 1-2-96)
K012027