HEMI IMPLANT; MINI HEMI IMPLANT

K102401 · Vilex, Inc. · KWD · Jul 20, 2011 · Orthopedic

Device Facts

• Record ID: K102401
• Device Name: HEMI IMPLANT; MINI HEMI IMPLANT
• Applicant: Vilex, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Jul 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement. The Vilex cannulated metallic hemi implant is intended for single use only.

Device Story

One-piece cannulated metallic hemi-arthroplasty implant; designed to resurface base of proximal phalanx in MTP joint. Implanted by surgeon; fixation via bone cement or press-fit. Provides mechanical replacement for damaged articular surface; restores joint function; reduces pain. Single-use device.

Clinical Evidence

Bench testing only; engineering analysis performed to demonstrate mechanical integrity and resistance to bending torques equivalent to predicate devices.

Technological Characteristics

One-piece cannulated hemi-arthroplasty implant. Materials: Cobalt chrome molybdenum alloy or Titanium Ti6Al4V. Optional Hydroxyapatite (HA) coating. Fixation: Cemented or press-fit. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients with degenerative or post-traumatic arthritis of the MTP joint, Hallux Limitus, Hallux Valgus, Hallux Rigidus, or unstable/painful MTP joint, provided good bone stock and phalangeal base integrity exist.

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 Metallic Hemi Implant (K023684)
• BioPro Hemi Joint with optional coating (K041595)
• Townley Great Toe Joint: BioPro (K911378)
• Metasurg Hemi Joint (K084369)
• OsteoMed Resurfacing Metatarsal Implant with HA Coating (K081876)
• FUTURA Biomedical (K971047)

Submission Summary (Full Text)

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## 510(k) Summary, K102401

| Sponsor: | Vilex in Tennessee, Inc., 111 Moffitt St., McMinnville, TN 37110,<br>931-474-7550 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sylvia Southard Date: July 8, 2011 |
| Device Name: | Cannulated Metallic Hemi Implant |
| Classification: | 21 CFR 888.3730 – Toe joint phalangeal (hemi-toe) polymer prosthesis, KWD |
| Predicate Devices: | K023684 Vilex Cannulated Metallic Hemi Implant<br>K041595 BioPro Hemi Joint with optional coating<br>K911378 Townley Great Toe Joint8: BioPro<br>K084369 Metasurg Hemi Joint<br>K081876 OsteoMed Resurfacing Metatarsal Implant with HA Coating<br>K971047 FUTURA Biomedical |
| Description of Device: | Vilex Cannulated Metallic Hemi Implant is a one-piece device intended to<br>resurface the base of the proximal phalanx. It is similar in design to the<br>predicate devices (BioPro K023684) and MetaSurg (K083469) in terms of<br>articular surface shape and fixation. Implants will be offered in cobalt chrome<br>or titanium, with or without Hydroxyapatite (HA) coated stem and back as an<br>option. |
| Material: | Cobalt chrome molybdenum alloy or Titanium Ti6Al4V (optional). The implant<br>may be cemented to the phalanx or press-fit without cement. |
| Indications for Use: | The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for<br>the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of<br>patients with degenerative and post-traumatic arthritis in the MTP joint in the<br>presence of good bone stock and integrity of the phalangeal base, along with<br>the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus,<br>and an unstable or painful MTP joint.<br><br>The Vilex cannulated metallic hemi implant is intended to be used with bone<br>cement or press fit without bone cement.<br><br>The Vilex cannulated metallic hemi implant is intended for single use only. |
| Non-Clinical Test Data | Based on the engineering analysis, the Vilex implants are equivalent to<br>predicates in terms of mechanical integrity and resistance to bending torques. |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Vilex Implants are<br>substantially equivalent to other legally marketed devices with and without HA<br>coating. The methods used to establish equivalence are comparisons of<br>indications for use, materials of construction, sizes, shapes, and mechanical<br>integrity analysis. |
| Establishment Reg. No.: | 1051526 |

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

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

JUL 2 0 2011

Re: K102401

Trade/Device Name: Vilex Cannulated Metallic Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: July 8, 2011 Received: July 14, 2011

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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Sylvia Southard

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Eunice Keith

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

510(k) Number: K102401

Device Name: Vilex Cannulated Metallic Hemi Implant

Indications for Use:

The Vilex cannulated metallic hemi implant, a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions; Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint.

The Vilex cannulated metallic hemi implant is intended to be used with bone cement or press fit without bone cement.

The Vilex cannulated metallic hemi implant is intended for single use only.

Prescription Use (Part 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)

for N. Melkerson

(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102401