MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000

K091763 · Instratek, Inc. · HTN · Aug 14, 2009 · Orthopedic

Device Facts

• Record ID: K091763
• Device Name: MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
• Applicant: Instratek, Inc.
• Product Code: HTN · Orthopedic
• Decision Date: Aug 14, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Michelangelo Bunion System is intended for the following surgical indication: To assist in the correction of hallux valgus deformities by providing reduction of the 1st intermetatarsal angle.

Device Story

Michelangelo Bunion System is a surgical implant system designed to assist in the correction of hallux valgus deformities by reducing the 1st intermetatarsal angle, potentially eliminating the need for traditional osteotomy. The device consists of three implanted components: a medial plate, a lateral plate, and a suture. Six accessories are required for implantation: suture lasso, k-wire, cannulated drill bit, k-wire guide, plate bender, and suture scissor. The system is used by surgeons in a clinical/surgical setting. By providing mechanical reduction of the intermetatarsal angle, the device stabilizes the bone alignment, facilitating correction of the deformity.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, specifically knot pull testing, which was performed in conjunction with the predicate device submission.

Technological Characteristics

Metallic bone fixation appliance consisting of medial and lateral plates and a suture. Designed for 1st intermetatarsal angle reduction. Class II device (21 CFR 888.3030).

Indications for Use

Indicated for patients requiring correction of hallux valgus deformities by providing reduction of the 1st intermetatarsal angle (up to and including 16 degrees).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• HAV-Lok Bunion Correction System (K082384)
• Arthrex Mini-Tightrope (K061925)

Submission Summary (Full Text)

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Special 510(k)

K091763

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| 510(k) Summary |
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| Submitter: | Instratek, Inc.<br>210 Springhill Drive<br>Suite 130<br>Spring, TX 77386 |
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| | AUG 14 2009 |
| Contact person: | Mr. Jeff Seavey<br>Vice President |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date summary prepared: | June 12, 2009 |
| Device trade name: | Michelangelo Bunion System |
| Device common name: | Button/Suture |
| Device classification name: | Washer,Bolt Nut, HTN at 21 CFR 888.3030 |
| Legally marketed devices to which the device is substantially equivalent: | HAV-Lok Bunion Correction System, K082384<br>Arthrex Mini-Tightrope, K061925 |
| Description of the device: | The Instratek Michelangelo Bunion System is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st. intermetatarsal angle.<br>Like the predicate device, the Michelangelo Bunion System is intended to assist in the correction of hallux valgus deformities by providing reduction of 1st intermetatarsal angles up to and including 16 degrees. The Michelangelo Bunion System may eliminate the necessity of a traditional osteotomy in the correction of Hallux Valgus deformities within the indicated criteria. The implanted device consists of three components <ol><li>Medial Plate</li><li>Lateral Plate</li><li>Suture</li></ol> There are 6 accessories required to implant the device <ol><li>suture lasso</li><li>kwire</li><li>cannulated drill bit</li><li>kwire guide</li><li>plate bender</li><li>suture scissor</li></ol> |

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| Intended use of the<br>device: | The Michelangelo Bunion System is intended for the following<br>surgical indication:<br>• To assist in the correction of hallux valgus deformities by<br>providing reduction of the 1st intermetatarsal angle. |
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| Technological<br>characteristics: | The technological characteristics between the predicate and<br>proposed devices are the same. |
| Performance tests: | Performance tests included knot pull testing which was performed<br>with the predicate device submission. |
| Conclusions: | There are no significant differences between the proposed and<br>predicate device; therefore, the proposed device does not raise<br>any questions regarding safety and effectiveness.<br>The Michelangelo Bunion System, as designed, is as safe and<br>effective as the predicate devices. Comparisons have been made<br>to a legally marketed predicate device, and the device is<br>determined to be substantially equivalent to the referenced<br>predicate device currently on the market. |

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

## AUG 1 4 2009

Instratek, Inc. % Mr. Jeff Seavey 210 Springhill Drive, Suite 130 Spring, Texas 77386

Re: K091763

Trade/Device Name: Michelangelo Bunion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: July 15, 2009 Received: July 23, 2009

Dear Mr. Seavey:

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 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); 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.

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Page 2 - Mr. Jeff Seavey

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrb/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Callen Bucheld

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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## INDICATIONS FOR USE STATEMENT

- 510(k) Number:

Device Name:

Indications for Use:

## K091763

Michelangelo Bunion System

The Michelangelo Bunion System is intended for the following surgical indication:

- To assist in the correction of hallux valgus deformities . by providing reduction of the 1st intermetatarsal angle.
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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yaukey I. Saye

1041765

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

510(k) Number