MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION

K070052 · Vilex, Inc. · KWD · Mar 28, 2007 · Orthopedic

Device Facts

• Record ID: K070052
• Device Name: MET-HEAD MODEL# MHDD-XX:CC DIAMETER, CC CANNULATION
• Applicant: Vilex, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Mar 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hallux Limitus or Rigidus Halux Valgus Metatarsal/Phalangeal (MTP) Joint To fixate, use cement or press fit without cement

Device Story

Met-Head™ is a metallic hemi-arthroplasty implant for the great toe. Machined from cobalt-chrome alloy; features spherical, mirror-polished head and cannulated, threaded stem for self-reaming/self-tapping fixation. Used by orthopedic surgeons in clinical settings to resurface arthritic MTP joints. Implanted via press-fit or bone cement. Auxiliary instruments provided for alignment and countersinking. Device restores joint surface, potentially reducing pain and improving function for patients with hallux conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Cobalt-chrome alloy. Design: Cannulated, threaded stem; spherical, mirror-polished head. Fixation: Self-reaming/self-tapping screw mechanism; compatible with bone cement or press-fit. Form factor: Hemi-arthroplasty prosthesis for MTP joint.

Indications for Use

Indicated for patients with Hallux Limitus, Hallux Rigidus, or Hallux Valgus requiring resurfacing of the Metatarsal/Phalangeal (MTP) joint.

Regulatory Classification

Identification

A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

Predicate Devices

• Vilex Cannulated Hemi Implant (K023684)
• STD Great Toe Resurfacing Hemi-Arthroplasty Implant (K031859)

Submission Summary (Full Text)

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## SUMMARY

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## Met-Head™, Resurfacing Hemi-Arthroplasty Implant

The implant is a fixation metal device, machined from implant quality cobalt-chrome alloy. The implant is cannulated to allow proper positioning. The stem is threaded and functions as a selfreaming and self-tapping screw for easy insertion. The shaft design is a duplicate of Vilex Cannulated Hemi Implant, K023684. The head is spherical and mirror-polished. The outside appearance resembles the STD Great Toe Resurfacing Hemi-Arthroplasty Implant, K031859. Use Only with Approved Bone Cement

Auxiliary instruments for implanting, aligning, countersinking come with "The Met-head."

| Date of submission | December 26, 2006, rev4: March 13, 2007 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Type of submission | 510(k); K070052 |
| Reason for submissi | New Device |
| Product Code | KUD |
| Device Class | II |
| Classification Panel | Orthopedics |
| Predicate Devices: | |
| K023684 | Vilex |
| K031859 | STD Manufacturing |
| Common/Generic | Phalangeal (Hemi Toe) Prosthesis |
| Device Trade Name | Met-HeadTM |
| Establishment Reg. | 2529556 |
| Owner Operator No. | 9004058 |
| Establishment | Manufacturer |
| Operations | |
| Indication for Use | Hallux Limitus or Rigidus<br>Resurfacing of Arthritic /Metatarsal joint<br>To fixate, use cement or press fit without cement |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vilex, Inc % Ms. Sylvia Southard President 111 Moffitt Street McMinnville, Tennessee 37110

MAR 2 8 2007

Re: K070052

Trade/Device Name: Met-Head™ Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: December 26, 2006 Received: January 10, 2007

Dear Ms. Southard:

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.

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Page 2 - Ms. Sylvia Southard

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 vours.

Rarbaro Bueto

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

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for VILEX Inc. The logo is in a bold, sans-serif font and is enclosed in a rectangular box. The word "Inc." is located to the right of the box.

| Manufacturer of Vilex™ bone implants,<br>Power equipment & surgical instruments | |
|---------------------------------------------------------------------------------|---------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| | 111 Moffitt Street |
| | McMinnville, TN 37110 USA |
| www.vilex.com | E-mail: [e-mail] |

510 (K) NUMBER K070052

DEVICE NAME: Toe Joint, Phalangeal (Hemi Toe) Prosthesis, Trade Name "Met-Head™»

## INDICATIONS FOR USE:

The Vilex "The Met-head", as designed, has the following Indications for Use:

Hallux Limitus or Rigidus Halux Valgus Metatarsal/Phalangeal (MTP) Joint To fixate, use cement or press fit without cement

Mark N Milkeuson

Prescription Use × (Per 21 CFR 801 Subpart D) Division of General, Restorative, and Neurological Devices

**510(K) Number** K076052

Concurrence of CDRH, Office of Device Evaluation (ODE)

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