ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM

K122497 · Medical Design, LLC · KWQ · Oct 15, 2012 · Orthopedic

Device Facts

• Record ID: K122497
• Device Name: ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
• Applicant: Medical Design, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Asfora Anterior Cervical Plate System provides temporary anterior cervical spine stabilization during fusion. System consists of titanium plates (1-4 levels) and bone screws; manual locking mechanisms (preassembled locking rings with tabs) prevent screw back-out. Surgeon implants device via anterior approach; screws inserted through plate into vertebral bodies. Device supports fusion development in patients with degenerative disc disease, trauma, or deformity. Benefits include mechanical stabilization of spinal segments. Device is non-sterile; requires hospital steam sterilization before use.

Clinical Evidence

Bench testing only. Mechanical integrity verified per ASTM F1717, including static and dynamic compression bending and static torsion testing to ensure device withstands clinical loading.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F136). Principle: Anterior interbody screw fixation with manual locking mechanism. Components: Plates (23-93 mm), screws (4.0-5.0 mm diameter). Sterilization: Non-sterile, steam sterilization recommended. Connectivity: None.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-T1) during fusion development. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

• Synthes Anterior CSLP System (K030866)
• Trinica Select™ Anterior Cervical Plate System (K022344)

Submission Summary (Full Text)

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# K122497

# 510(k) Summary

OCT 15 2012

| Submitter: | Medical Designs, LLC<br>6709 S. Minnesota Ave, Suite 204<br>Sioux Falls, South Dakota 57108-2593 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristi Vondra, Vice President of Operations<br>Tel: [phone]<br>FAX: [phone] |
| Date Prepared: | August 15, 2012 |
| Trade Name: | Asfora Anterior Cervical Plate System |
| Classification: | Class II<br>Spinal intervertebral body fixation orthosis<br>21 CFR §888.3060 |
| Product Code: | KWQ |
| Predicate<br>Device(s): | The subject device is substantially equivalent to the following devices:<br>• Synthes Anterior CSLP System (Synthes, K030866)<br>• Trinica Select™ Anterior Cervical Plate System (Centerpulse<br>Spine-Tech, K022344), currently marketed by Zimmer Spine |
| Device<br>Description: | The Asfora Anterior Cervical Plate System is composed of plates of<br>varying lengths to accommodate surgical procedures from one to four<br>levels. The plates are designed for application to the anterior aspect of<br>the cervical spine and have manual locking mechanisms to reduce the<br>potential for screws to back out of the vertebral body. The screws are<br>provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from<br>14mm to 16mm |
| Intended Use: | The Asfora Anterior Cervical Plate System is intended to provide<br>temporary stabilization to the anterior spine during the development of<br>cervical spine fusions (C2-T1) for the following indications:<br>degenerative disc disease (DDD) (defined as neck pain of discogenic<br>origin with degeneration of the disc confirmed by history and<br>radiographic studies), spondylolisthesis, trauma (i.e., fracture or<br>dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,<br>kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous<br>fusion |

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# Substantial Equivalence:

| Similarities to Predicate Devices | | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | Medical Designs<br>Cervical Plate<br>System<br>(Subject Device) | Synthes Anterior<br>CSLP System<br>(K030866) | Centerpulse<br>Spine-Tech<br>Trinica Select™<br>Anterior Cervical<br>Plate System<br>(K022344) |
| Intended Use | The cervical plate<br>system is intended<br>for use in anterior<br>interbody screw<br>fixation of the<br>cervical spine. | same | same |
| Principle of<br>Operation | Fixation is<br>achieved by<br>inserting bone<br>screws through<br>openings in the<br>plate into the<br>vertebral bodies of<br>the cervical spine. | same | same |
| System<br>Components | Plates (1-4<br>levels)<br>Locking<br>Screws<br>Screw locking<br>mechanisms | same | same |
| Material | Titanium<br>(Ti-6Al-4V alloy<br>per ASTM F136) | same<br>(Implant grade<br>commercially pure<br>titanium) | same<br>(Ti-6Al-4V alloy<br>per ASTM F136) |
| Sterility | Non-Sterile.<br>Hospital steam<br>sterilization<br>recommended | same | same |
| Differences from Predicate Devices | | | |
| Parameter | Medical Designs<br>Cervical Plate<br>System<br>(Subject Device) | Synthes Anterior<br>CSLP System<br>(K030866) | Centerpulse<br>Spine-Tech<br>Trinica SelectTM<br>Anterior Cervical<br>Plate System<br>(K022344) |
| Indications for<br>Use Statement | The Asfora The<br>Asfora Anterior<br>Cervical Plate<br>System is intended<br>to provide<br>temporary<br>stabilization to the<br>anterior spine<br>during the<br>development of<br>cervical spine<br>fusions (C2-T1)<br>for the following<br>indications:<br>degenerative disc<br>disease (DDD)<br>(defined as neck<br>pain of discogenic<br>origin with<br>degeneration of<br>the disc confirmed<br>by history and<br>radiographic<br>studies),<br>spondylolisthesis,<br>trauma (i.e.,<br>fracture or<br>dislocation),<br>spinal stenosis,<br>deformities or<br>curvatures (i.e.,<br>scoliosis,<br>kyphosis, and/or<br>lordosis), tumor,<br>pseudoarthrosis,<br>and failed<br>previous fusion | The Synthes Anterior<br>CSLP System is<br>intended for anterior<br>screw fixation to the<br>cervical spine (C2-<br>C7) for the following<br>indications:<br>1. Spondylolisthesis<br>2. Fracture<br>3. Spinal stenosis<br>4. Tumor<br>Degenerative disc<br>disease (as defined by<br>neck pain of<br>discogenic origin<br>with degeneration of<br>the disc confirmed by<br>patient history and<br>radiographic studies). | The<br>Trinica/Trinica<br>Select Anterior<br>Cervical Plate<br>System is intended<br>for anterior<br>interbody screw<br>fixation of the<br>surgical spine at<br>levels C2-T1. The<br>system is<br>indicated for use<br>in the temporary<br>stabilization of the<br>anterior spine<br>during the<br>development of<br>cervical spine<br>fusions in patients<br>with degenerative<br>disc disease (as<br>defined by neck<br>pain of discogenic<br>origin of the disc<br>confirmed by<br>patient history and<br>radiographic<br>studies), trauma<br>(including<br>fractures), tumors,<br>deformity (defines<br>as kyphosis,<br>lordosis, or<br>scoliosis),<br>pseudoarthrosis,<br>and/or failed<br>previous fusions. |
| Plate Lengths | 23-93 mm | 23-109 mm | 22-92mm |
| Locking Screw<br>Size | • Ø 4.0 mm<br>14-16 mm | • Ø 4.0-4.5mm<br>12-20 mm length | • Ø 4.2-4.6 mm<br>12-20 mm length |
| Screw Locking<br>Mechanisms | Locking rings are<br>preassembled onto<br>the plate and<br>include anti-<br>rotational locking<br>features and safety<br>locking tabs that<br>engage to prevent<br>the screws from<br>backing out. | The system includes<br>expansionhead<br>screws and locking<br>screws which lock to<br>the plate. | Locking caps are<br>preassembled onto<br>the plate and are<br>designed with tabs<br>that prevent bone<br>screws from<br>backing out. |
| Additional Screw<br>Types | Temporary<br>Fixation : Ø 3.5<br>mm, 14 mm<br>Rescue: Ø 5.0<br>mm, 14 mm and<br>Ø 5.0 mm, 16 mm | none | Threaded<br>temporary fixation<br>pins, sizes not<br>available |

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K122417
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Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff Spinal System 510(k)s and safety testing using ASTM F 1717 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose. Testing included static and dynamic compression bending, and static torsion.

#### Medical Designs, LLC considers the Asfora Anterior Cervical Plate System to be equivalent to the predicate devices listed above. This Conclusion: conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

Functional and

Safety Testing:

K 122497 4 of 1

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT
15
2012

Medical Designs, LLC % Ms. Kristi Vondra Vice President of Operations . 6709 South Minnesota Avenue, Suite 204 Sioux Falls, South Dakota 57108-2593

Re: K122497

Trade/Device Name: Asfora Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 15, 2012 Received: August 16, 2012

Dear Ms. Vondra:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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#### Page 2 - Ms. Kristi Vondra

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4.0 Indications for Use Statement

Device Name: Asfora Anterior Cervical Plate System

The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use X (Part 21 CFR 801 Subpart D

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Over-The-Counter Use (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)

Cal-R

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122497

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