SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM

K070295 · Trinity Orthopedics, LLC · MNI · May 21, 2007 · Orthopedic

Device Facts

• Record ID: K070295
• Device Name: SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
• Applicant: Trinity Orthopedics, LLC
• Product Code: MNI · Orthopedic
• Decision Date: May 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single Planar Multi Axial (SPMA) Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Device Story

SPMA Pedicle Screw System is an internal spinal fixation device; consists of rods and pedicle screw assemblies (screw, saddle, axle, locking washer, set screw). Axle allows saddle to adjust in single plane up to 60° from midline. Grooved locking washer and screw head interdigitate with splined rod surface to provide rigid fixation when tightened. Used by surgeons in clinical settings to stabilize spinal segments. Rods provided in titanium alloy and Co-Cr-Mo alloy. Manual surgical instruments assist insertion. System provides mechanical stabilization to facilitate fusion, potentially reducing pain and correcting spinal deformities.

Clinical Evidence

Bench testing only. Mechanical testing performed on the SPMA Pedicle Screw System using titanium rods demonstrated equivalence to legally marketed predicate devices.

Technological Characteristics

Internal fixation system; components include titanium alloy and Co-Cr-Mo alloy rods (6.0 mm diameter) and cannulated titanium alloy screws. Features proximal articulating saddle with transverse axle allowing 60° single-plane angulation. Rigid fixation achieved via interdigitation of grooved locking washer/screw head with splined rod surface. Manual instrumentation used for placement.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including degenerative spondylolisthesis with neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous 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

• OPTIMA Spinal System (K051971)
• MOSS Miami Spinal System (K955348, K982511, K983583, K022623)
• Stryker Xia Spinal System (K001272, K043473, K060979, K063428)
• CD HORIZON Spinal System (K961633, K001255)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

MAY 2 1 2007

# Trinity Orthopedics, LLC Single Planar Multi Axial (SPMA) Pedicle Screw System

## ADMINISTRATIVE INFORMATION

Manufacturer Name:

Trinity Orthopedics, LLC 8817 Production Avenue San Diego, CA 92121 Telephone [phone] Fax [phone]

Official Contact:

Representative/Consultant:

James F. Marino, M.D.

Flovd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] Fax [phone] email: [e-mail]

## DEVICE NAME

| Classification Name: | Pedicle Screw Spinal System |
|-------------------------|-----------------------------|
| Trade/Proprietary Name: | SPMA Pedicle Screw System |
| Common Name: | Pedicle Screw System |

## DEVICE CLASSIFICATION

FDA has classified "Pedicle Screw Spinal System" as Class II devices (21 CFR 888.3070), with a product codes of MNI and MNH.

## INTENDED USE

The Single Planar Multi Axial (SPMA) Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal turnor, pseudoarthrosis, and failed previous fusion.

{1}------------------------------------------------

## DEVICE DESCRIPTION

The SPMA Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods and pedicle screw assemblies (screw, saddle, axle, locking washer and set screw). The axle that connects the screw to the saddle allows the saddle to be adjusted in a single plane to any angle, up to 60 ° from the midline. Grooves in the head of the screw and in the inferior face of the locking washer interdigitate with the splined surface of the rod to allow the assembly to be rigidly fixed in place when tightened.

#### Component Description

#### Rod

SPMA Pedicle Screw System rods are 6.0 mm diameter solid splined cylinders which are provided non-contoured and pre-contoured to accommodate the lordotic curve. Precontoured rods and standard non-contoured rods are available in a variety of lengths. The rods fit into the pedicle screw saddle of the pedicle screw assembly. After the rods are placed in the pedicle screw saddle, the locking washer and set screw are secured to the pedicle screw. The rods are provided in titanium alloy and Co-Cr-Mo alloy.

#### Pedicle Screw Assembly

Each SPMA pedicle screw assembly consists of a cannulated titanium alloy screw with a proximal articulating saddle held in place with a transverse axle. The axle joining the mating surfaces of the screw and saddle allows for up to 60° angulation from midline in a single plane.

The locking washer is placed atop the rod within the saddle and held in place with the set screw. The grooved design of the locking washer and the proximal end of the screw allow for close interdigitation with the splined surface of the rod, fixing the angle of the saddle.

## Additional Components

A series of manual surgical instruments (not subject of this submission) intended to assist the insertion and placement of the implants (pedicle screws, rods, set screws, and locking washers) is included in an instrument tray.

## PERFORMANCE TESTING

Mechanical testing performed on the SPMA Pedicle Screw System using titanium rods demonstrated equivalence of the device to legally marketed predicate devices.

{2}------------------------------------------------

## EQUIVALENCE TO MARKETED PRODUCT

Trinity Orthopedics, LLC submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SPMA Pedicle Screw System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: OPTIMA™ Spinal System (K051971) from U & I Corporation, the MOSS® Miami Spinal System (K955348, K982511, K983583, K022623) from DePuy AcroMed, Inc., the Stryker Xia® Spinal System (K001272, K043473, K060979, K063428) from Stryker Spine, and the CD HORIZON® Spinal System (K961633, K001255) from Medtronic Sofamor Danek, Inc.

The SPMA Pedicle Screw System has the following similarities to the predicate devices:

- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design, and
- · incorporates the same materials.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trinity Orthopedics, LLC % Mr. Floyd G. Larson Paxmed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

MAY 2 1 2007

Re: K070295

Trade/Device Name: Single Planar Multi Axial (SPMA) Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: April 25, 2007 Received: April 27, 2007

Dear Mr. Larson:

We have reviewed your 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.

{4}------------------------------------------------

Page 2 -- Mr. Floyd G. Larson

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Barbara Buehrle
to

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 4 – Mr. Floyd G. Larson

## OC Numbers:

| Division of Enforcement A | 240-276-<br>0115 |
|------------------------------------------------------------------------------------|------------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-<br>0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-<br>0115 |
| General Hospital Devices Branch | 240-276-<br>0115 |
| General Surgery Devices Branch | 240-276-<br>0115 |
| Division of Enforcement B | 240-276-<br>0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-<br>0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices and<br>Radiological Devices | 240-276-<br>0120 |

.

{6}------------------------------------------------

## Indications for Use

Applicant:

Trinity Orthopedics, LLC

510(k) Number (if known):

Device Name:

Single Planar Multi Axial Pedicle Screw System

Indications for Use:

The Single Planar Multi Axial (SPMA) Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harbare hneup

and

510(k) Number K070295

Image /page/6/Picture/17 description: The image shows the text "pg 1 of 1" crossed out, with the text "Page 16 of 276" written below it. The text "pg 1 of 1" appears to be handwritten, while the text "Page 16 of 276" appears to be printed. The image suggests that the page number is 16 out of a total of 276 pages.