ASFORA BULLET CAGE

K112648 · Medical Designs, LLC · MAX · Mar 13, 2012 · Orthopedic

Device Facts

• Record ID: K112648
• Device Name: ASFORA BULLET CAGE
• Applicant: Medical Designs, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Mar 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.

Device Story

Asfora Bullet Cage (ABC) is a threaded, self-tapping, bullet-shaped, hollow-body intervertebral fusion device; constructed of titanium alloy; includes a threaded titanium end cap. Used by surgeons in spinal fusion procedures to immobilize adjacent vertebrae and promote arthrodesis across the disc space. Implanted in the lumbar spine (L2-S1) via posterior approaches (PLIF/TLIF) requiring supplemental fixation. Device is filled with autogenous bone graft to facilitate fusion. Available in multiple diameters (10-18mm) and lengths (21-25mm). Provides mechanical stability to the disc space, potentially reducing pain and restoring spinal alignment in patients with degenerative disc disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Threaded, self-tapping, bullet-shaped, hollow-body intervertebral fusion cage. Material: Titanium alloy. Dimensions: 5 diameters (10mm, 12mm, 14mm, 16mm, 18mm) and 2 lengths (21mm, 25mm). Mechanical device; no software or energy source.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) and instability at 1-2 contiguous levels (L2-S1). Includes patients with up to Grade I spondylolisthesis. Requires 6 months of failed non-operative treatment. Contraindicated for patients not meeting skeletal maturity or those without discogenic back pain.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Asfora Bullet Cage System (K090048)
• Ray TFC Threaded Fusion Cage (P950019/S9)

Submission Summary (Full Text)

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## 6.0 510(k) Summary_

| 6.0 510(k) Summary | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Medical Designs, LLC<br>1210 W. 18th Street, Suite 104<br>Sioux Falls, South Dakota 57104 |
| Contact Person: | Kristi Vondra<br>Vice President of Operations<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | September 8, 2011 |
| Trade Name: | Asfora Bullet Cage™ System, Intervertebral Body Fusion Device |
| Classification: | Class II<br>Intervertebral Body Fusion Device<br>21 CFR 888.3080 |
| Product Code: | MAX |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K090048, Asfora Bullet Cage System<br>• P950019/S9 Ray TFC Threaded Fusion Cage (down-classified to Class II) |
| Device Description: | The Asfora Bullet Cage (ABC) is a threaded titanium alloy interbody fusion<br>device (cage) with a threaded titanium end cap.<br>The ABC is a threaded, self-tapping, bullet-shaped, hollow-body, device<br>designed to immobilize adjacent vertebrae and promote arthrodesis (fusion)<br>across the disc space. The Asfora Bullet Cage is available in ten sizes: 5<br>diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm<br>or 25mm). |
| Intended Use: | The Asfora Bullet Cage® is indicated for spinal fusion procedures in<br>skeletally mature patients with degenerative disc disease (DDD) and<br>instability in the lumbar spine at one or two contiguous levels from L2 to S1.<br>DDD for lumbar systems is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies. The<br>DDD patients may also have up to Grade I spondylolisthesis at the involved<br>level(s). The ABC cage devices are used with autogenous bone graft.<br>Patients should be skeletally mature and have had at least six (6) months of<br>non-operative treatment prior to implant. When implanted via a posterior<br>(PLIF, TLIF) approach, this device should be used with supplemental<br>fixation. |
| Functional and<br>Safety Testing: | No significant changes to the design of the device were made. Risk<br>assessment was performed which concluded no additional testing was<br>required. |
| Conclusion: | Medical Design, LLC considers the device name to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices'<br>similarities in principles of operation, technology, materials and indications<br>for use. |

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

Medical Designs, LLC % Ms. Kristi Vondra VP of Operations 1210 W. 18th Street, Suite 104 Sioux Falls, South Dakota 57104

MAR 1 3 2012

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Re: K112648

Trade/Device Name: Asfora Bullet Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 17, 2012 Received: February 21, 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/ycm115809.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,

fee Dettler
N. Wells
Osceola, Pa.

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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## 5.0 Indications For Use Statement

510(k) Number: K112648

Device Name: Asfora Bullet Cage System

Indications for Use:

The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.

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

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)

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

K112648 510(k) Number_

Medical Designs, LLC Special 510(k) Response to Questions K112648

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