TANTALUM BEAD SET, MODEL P003175

K090581 · Halifax Biomedical, Inc. · NEU · Aug 21, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090581
• Device Name: TANTALUM BEAD SET, MODEL P003175
• Applicant: Halifax Biomedical, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Aug 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Tantalum Bead Set is to be used with the Halifax RSA Bead Inserter. Tantalum beads are to be used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

Device Story

Tantalum Bead Set consists of 1mm spherical, unalloyed tantalum markers; used as radio-opaque reference points for monitoring orthopaedic implant migration. Beads are supplied in PEEK cartridges; deployed into bone or soft tissue using manual Halifax RSA Bead Inserter. Device is non-sterile; requires hospital-performed sterilization. Clinicians use x-ray imaging to visualize beads post-operatively; bead position changes relative to implants indicate movement. Facilitates assessment of implant stability following joint replacement, soft tissue repair, or fracture fixation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to the predicate device.

Technological Characteristics

1mm spherical markers; material: commercially pure, unalloyed tantalum. Cartridge material: PEEK. Deployment: manual surgical inserter. Sterilization: hospital-performed. Connectivity: none (passive radiographic markers).

Indications for Use

Indicated for use as radio-opaque markers implanted into bone or soft tissue to measure post-surgical implant movement via x-ray. Applicable to patients undergoing total joint replacement, soft tissue repair, or bone fracture fixation.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Tantalum Beads, Biomet, Inc. (K010348)

Submission Summary (Full Text)

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Halifax Biomedical Inc. Traditional 510(k)

# 510(k) Summary of Safety and Effectiveness

| Manufacture Name: | Halifax Biomedical Inc. |
|-------------------|---------------------------------------------------------|
| Contact Name: | Chad Munro, P.Eng, MASc (Biomed.) |
| Postal Address: | 11493 Route 19<br>Mabou, Nova Scotia,<br>Canada B0E 1X0 |
| Phone Number: | 902-945-2771 |
| Fax: | 902-945-2324 |
| Contact: | Chad Munro, P.Eng, MASc (Biomed.) |
| Title: | President |
| Date: | February 6, 2009 |

| Device Proprietary Name: | Tantalum Bead Set |
|------------------------------|-----------------------------------|
| Device Common or Usual Name: | Radiographic Marker |
| Classification Name: | Marker, Radiographic, Implantable |
| Classification Code | NEU - Class II |
| Classification Panel | General & Plastic Surgery |
| Regulation Number | 878.4300 |

### Predicate Device:

Substantial equivalence is claimed to the following device as related to intended use and design characteristics:

- . Tantalum Beads, Biomet, Inc. K010348
#### Description of the Device

The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. They are used as radio-opague markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray. The beads are applied with a manual surgical instrument. The beads are provided non-sterile in a cartridge which includes 16 beads. The cartridge, manufactured from PEEK is designed to be used with the Halifax RSA Bead Inserter (Class 1 device) to allow surgeons to deploy the beads into the bone and tissue surrounding an orthopaedic implant. The inserter and cartridge containing the beads must be sterilized by the hospital prior to use.

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Halifax Biomedical Inc. Traditional 510(k)

Tantalum Bead Set K090581

K090581

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# Intended Use of the Device

The Tantalum Bead Set is to be used with the Halifax RSA Bead Inserter. Tantalum beads are to be used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

Clinical use references for tantalum markers are provided in Appendix A.

# Substantial Equivalence

The Tantalum Bead Set is equivalent to the Biomet Tantalum Bead product based on the intended use, design, technology, material composition and performance.

### Conclusion

Based on the information provided in this 510(k) premarket notification, the Tantalum Bead Set is substantially equivalent in terms of safety and effectiveness to the predicate device identified above.

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

Halifax Biomedical, Inc. % Canreg, Inc. Roshana Ahmed Regualtory Affairs Manager, Devices 4 Innovation Drive Dundas, Ontario Canada L9H 7P3

AUG 21 2009

Re: K090581

Trade/Device Name: Tantalum Bead Set Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: August 11, 2009 Received: August 19, 2009

Dear Roshana Ahmed:

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

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## Page 2 - Roshana Ahmed

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/cdrl/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 tollefire number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sincerely yours,

Mark N. Malkerson

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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Tantalym Bead Set K090581

Halifax Biomedical Inc.. Traditional 510(k)

# Indications for Use

K090581 510(k) Number:

Device Name: Tantalum Bead Set

Indication for Use: Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an xray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation

Nil RP Qula for mkon

Division Sign-C Office of Device Evaluation Evaluation and Safety

510(k) K090581