THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES

K052072 · Abbott Spine, Inc. · KWQ · Aug 29, 2005 · Orthopedic

Device Facts

• Record ID: K052072
• Device Name: THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
• Applicant: Abbott Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following: Degenerative disc disease (DDD) - as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; Trauma (including fractures); Tumor; Spondylolisthesis; Spinal stenosis; Deformity (i.e., scoliosis, kyphosis, lordosis); Pseudarthrosis; and Failed previous fusions.

Device Story

The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is a spinal fixation device consisting of bone plates and screws. It is designed for anterior fixation to the cervical spine (C2-C7). The system features a mechanism that allows for uni-axial motion in compression, facilitating postoperative load sharing between the plate and the bone graft to support spinal fusion. The device is intended for use by surgeons in a clinical/hospital setting to stabilize the cervical spine in patients with documented instability. By providing structural support and enabling controlled motion, the device aids in the development of solid spinal fusion, potentially reducing the risk of hardware failure and improving patient outcomes in cases of degenerative disease, trauma, or deformity.

Clinical Evidence

No clinical data was required or provided for this device; substantial equivalence was established through non-clinical bench testing.

Technological Characteristics

The system consists of bone plates and screws designed for anterior cervical fixation. It utilizes a mechanical mechanism to allow uni-axial motion in compression for load sharing. The device is a spinal intervertebral body fixation orthosis (Product Code: KWQ).

Indications for Use

Indicated for patients (C2-C7) requiring spinal fusion due to degenerative disc disease, trauma, tumor, spondylolisthesis, spinal stenosis, deformity, pseudarthrosis, or failed previous fusions.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Spinal Concepts, Inc. (now Abbott Spine, Inc.) Ant-Cer Dynamic Anterior Cervical Plate System, K024326

Submission Summary (Full Text)

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# AUG 2 9 2005

# ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS

| SUBMITTER: | Abbott Spine (formerly Spinal Concepts, Inc.) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| DATE: | July 29, 2005 |
| TRADE NAME: | SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System |
| COMMON NAME: | Spinal Fixation System |
| CLASSIFICATION NAME: | KWQ: Spinal Intervertebral Body Fixation Orthosis |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3050 |
| PREDICATE DEVICE: | Spinal Concepts, Inc. (now Abbott Spine, Inc.) Ant-Cer Dynamic Anterior Cervical Plate System, K024326, cleared January 23, 2003. |

### DEVICE DESCRIPTION:

Divice Discurix Ant-Cer Dynamic Anterior Cervical Plate System consists of bone plates, The SC-Acul IX The Cor Dynamed for anterior fixation to the cervical spine. The plate system serews, and motioninentign that allows for uni-axial motion in compression to ensure postoperative load sharing between the plate and the graft.

#### INDICATIONS:

The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the The SC-Acul ix All Cor Dyname Panepine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

Degenerative disc disease (DDD) - as defined by neck pain of discogenic origin with ﻨﺴﺒ degeneration of the disc confirmed by patient history and radiographic studies;

- Trauma (including fractures); 2.
- Tumor; 3.
- Spondylolisthesis; 4.
- Spinal stenosis; న్.

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K os 5 207 a
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- Deformity (i.e., scoliosis, kyphosis, lordosis); 6.
- Pseudarthrosis; and 7.
- Failed previous fusions. 8.

The subject device is the result of design COMPARISON TO PREDICATE DEVICE: I he subject to the predicate device, has the same intended use, and is substantially equivalent to the predicate device. NON-CLINICAL PERFORMANCE AND CONCLUSIONS: PERFORMANCE DATA (NONCLINICAL AND/OR CLINICAL): Laboratory and bench testing results demonstrate that the proposed Ant-Cer device is substantially equivalent to the predicate device.

CLINICAL PERFORMANCE AND CONCLUSIONS:

Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K052072

K032072
Trade Name: SC-AcuFix™ Ant-Cer™ Dynamic Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: July 29, 2005 Received: August 1, 2005

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati we have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally mancties provice Americal Device American son to commerce prior to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval approval application (PMA). and Costnetic Act (Act) that do not require approvince approvisions of the Act. The Act. The You may, merciole, market the actives, bases of the more of registration, listing of
general controls provisions of the Act include requirements for annual registereding and general controls provisions of the rist 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 If your device is classified (sec above) into exist on a considerating your device can
may be subject to such additional controls. Existing major regal consected and them ED may be subject to such additional controls. Existing may of to 898. In addition, FDA may be found in the Code of Feach 1988.
publish further announcements concerning your device in the Federal Register.

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# Page 2 - Mr. Noah Bartsch

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualice of a substitive with other requirements of the Act
that FDA has made a determination that your device complies with of act that FDA has made a delerinmation that your as roo be roo be recension would be in or any Federal statules and regulations deminds. but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not areastice asset comply with an the Act s requirements, more 801); good manufacturing practice requirements as setting as set CFR Part 807), labeling (21 CFRT art 807), good and if applicable, the electronic forth in the quality systems (QD) regaliation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 product radiation control provisions (Declons of 1 evice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your d I his letter will anow you to oegin maneting your antial equivalence of your deventity ware development premarket notification. THC PDA miding of baction 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 If you desire specific advice for your ac-1.0. Also, please note the regulation entitled, and colliact the Office of Comphalled at (210) = 15 = 18 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = 1 " Misbranding by relefence to premanter noalities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

Mark N. Melkerson Acting 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

#### K052072 510(k) Number (if known):

## Device Name:

The SC-AcuFix™ Ant-Cer™ Dynamic Cervical Plate System

# Indications for Use:

The SC-AcuFix Ant-Cer Dynamic Anterior Cervical Plate System is indicated for use in the The SC-Acult ix Allt Oct Dyname i alspine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

- 1. Degenerative disc disease (DDD) as defined by neck pain of discogenic origin with Degenerative disc discusse (DDD) - ) - (DD) - ) - ) - ( - ) - ) - ( - ) - ) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- 2. Trauma (including fractures);
- 3. Tumor;
- 4. Spondylolisthesis;
- Spinal stenosis; 5.
- 6. Deformity (i.e., scoliosis, kyphosis, lordosis);
- 7. Pseudarthrosis; and
- 8. Failed previous fusions.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(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

KOS 2072 * (k) Number

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