MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS

K040990 · Walter Lorenz Surgical, Inc. · NEU · May 13, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040990
• Device Name: MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: May 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended Use

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

Clinical Evidence

No clinical data. Substantial equivalence based on technological characteristics and intended use comparison to predicate device.

Technological Characteristics

Zirconium bone screws; non-absorbable material. Self-drilling design for manual surgical application. Radiopaque for X-ray visualization. No software or electronic components.

Indications for Use

Indicated for use as radiopaque markers implanted into bone during orthopedic or other surgical procedures to measure implant movement or serve as anatomical reference points 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

• Stainless Steel Self Drilling Radiographic Marker (K014148)

Submission Summary (Full Text)

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**MAY 13 2004**

K04099D

# TAB 2 - Summary of Safety and Effectiveness

510(k) Summary (per 21 CFR 807.92(c))

### SUBMITTER

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

### PRODUCT NAME

Common/Usual Name: Radiographic Marker

Proprietary Name: Sclf-Drilling Radiographic Marker

### DEVICE CLASSIFICATION

The FDA has cleared radiographic markers via 510(k) Premarket Notification as Product Code THE FDA nas cicared radiographic 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.

## PREDICATE DEVICE

The predicate device is the Stainless Stecl Self Drilling Radiographic Marker cleared under W. Lorenz 510(k) number K014148 on January 17, 2002.

# DESCRIPTION OF DEVICE

The Self-drilling Radiographic Markers are zirconium 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 Xray. Self-drilling Radiographic Markers are applied with manual surgical instruments.

## INTENDED USE OF THE DEVICE

The Self-Drilling Radiographic Markers arc zirconium 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.

# STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES

Both the new and the old devices consist of non absorbable material (stainless steel, zirconium) Doth the FDA's Biomaterials Compendium and list of FDA recognized standards. Both the nsted in 1 Dre Dromaternal Sed devices are implanted into bone during surgical procedures precieee and and a surgical location (e.g. implant, prosthesis, or anatomic position). The metallic materials and intended use as radiographic markers are technically equivalent.

#### CONCLUSIONS

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2004

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

Re: K040990

Trade/Device Name: Self-Drilling Radiographic Markers Regulation Number: 21 CFR 878.4300 Regulation Name: Marker, radiographic, implantable Regulatory Class: II Product Code: NEU Dated: April 14, 2004 Received: April 16, 2004

Dear Ms. Reed:

We have reviewed your Scction 510(k) premarket notification of intent to market the device w & new le reveal 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 for assession in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner or with to may 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetor For (. 10. (. 10.) the device, subject to the general controls provisions of the Act. The r ou may, itere, whiless of the Act include requirements for annual registration, listing of general beliable profice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your de rise to such additional controls. Existing major regulations affecting your device can may or subject to basil and 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 equivalcnce determination does not mean r toabe oe actermination that your device complies with other requirements of the Act that 1197 Has Intatutes and regulations administered by other Federal agencies. You must or any I each 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 El It rate 6077, aboning (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) This letter with anow you to begin mailering of substantial equivalence of your device to a legally premarket notification. THP PDF intembers on 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 if you desire specific acrepliance 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 other general mionmation 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 yours,

Miriam C. Provost

(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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KO40920

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Self-Drilling Radiographic Markers Device Name: _________________________________________________________________________________________________________________________________________________________________

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 implantou into bone daving of implants or serve as a reference point to locate anatomical structures with the aid of an X-ray.

Prescription Use
(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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_________________________________________________________________________________________________________________________________________________________________