SELF-DRILLING RADIOGRAPHIC MARKER

K014148 · Walter Lorenz Surgical, Inc. · NEU · Jan 17, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K014148
• Device Name: SELF-DRILLING RADIOGRAPHIC MARKER
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

The Self-Drilling Radiographic Markers are stainless steel screws indicated for use as radiographic markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

Device Story

Self-Drilling Radiographic Markers are stainless steel bone screws; implanted into bone during orthopedic or surgical procedures. Device serves as radiopaque reference point; enables measurement of implant movement or anatomical structure localization via X-ray. Applied using manual surgical instruments. Used by surgeons in clinical/OR settings. Benefit: provides stable, radiographically visible markers for post-operative monitoring and surgical navigation.

Clinical Evidence

No clinical data. Substantial equivalence is based on technological characteristics and material biocompatibility.

Technological Characteristics

Stainless steel bone screws; non-absorbable material; manual application. Function as radiopaque markers. No software or electronic components.

Indications for Use

Indicated for use as radiopaque markers in patients undergoing orthopedic or other surgical procedures requiring bone implantation to measure implant movement or locate anatomical structures via X-ray.

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 Bead - Radiographic Marker (K010348)

Submission Summary (Full Text)

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K014148 (P.1 of 2)

# 510(k) SUMMARY (per 21 CFR 807.92 (c))

### 1. SUBMITTER

JAN 1 7 2002

Walter Lorenz Surgical, Inc.* 1520 Tradeport Drive Jacksonville, FL 32218 FDA Registration No. 1032347

*Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580 FDA Registration Number: 1825034

#### 2. PRODUCT NAME

Common/Usual Name: Radiographic Marker

Proprietary Name: Self-Drilling Radiographic Marker

### 3. DEVICE CLASSIFICATION

The FDA has cleared radiographic markers via 510(k) Premarket Notifications as Product Code NEU Marker, Radiographic, Implantable -Class II. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for implantable radiographic markers.

### 4. PREDICATE DEVICE

The predicate device is the Tantalum Bead - Radiographic Marker cleared under Biomet 510(k) number K010348 on May 3, 2001.

#### 5. DESCRIPTION OF THE DEVICE

Self-Drilling Radiographic Markers are stainless steel bone screws used as radiographic markers, and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants after surgery with the aid of an X-ray. Self-Drilling Radiographic Markers are applied with manual surgical instruments.

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K014148 (P.2 of 2)

### 6. INTENDED USE OF THE DEVICE

The Self-Drilling Radiographic Markers are stainless steel screws indicated for use as radiographic markers and may be implanted into bone during orthopedic or other surgical procedures. These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

# 7. STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES

Both the new and predicate devices consist of non absorbable material (stainless steel, tantalum) listed in the FDA's Biomaterials Compendium and list of FDA recognized standards. Both the predicate devices and the modified self-drilling devices are implanted into bone during surgical procedures to radiographically mark a surgical location (e.g. implant, prosthesis, or anatomic position). The metallic materials and intended use as radiographic markers are technically equivalent. The modified device is being added to resolve differences in surgeon preference.

#### 8. CONCLUSIONS

The use of modified stainless steel screws and the predicate tantalum beads as radiographic markers is substantially similar.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Ms. Kim Reed Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218

Re: K014148

Trade/Device Name: Self-Drilling Radiographic Markers Regulation Number: 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 17, 2001 Received: December 18, 2001

Dear Ms. Reed:

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. Kim Reed

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Mark A. Melham

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

510(k) Number K014148

Device Name: Self-Drilling Radiographic Markers

Indications for Use:

Self-Drilling Radiographic Markers are used as radiopaque markers and may be implanted into bone during orthopedic or other surgical procedures These devices are used to measure movement of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
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| | OR |
| | Over-The-Counter-Use<br>(Optional Format 1-2-96) |

for

(Division Sign-Off)

Division of General, ative
and Neurological De.....

| 510(k) Number | K014148 |
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