LORENZ SELF DRILLING SCREWS

K013954 · Walter Lorenz Surgical, Inc. · HWC · Feb 28, 2002 · Orthopedic

Device Facts

• Record ID: K013954
• Device Name: LORENZ SELF DRILLING SCREWS
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Internal fixation devices to aid the surgeon in the stabilization and fixation of oral micinal "itsanon" do recess" to "all bones of the hand, feet, wrist, ankles, fingers and toes, Craino-maximonomics, osteotomies, revision procedures, joint fusion and reconstructive procedures.

Device Story

Self-drilling bone screws; 1.5 mm to 2.0 mm diameter; cross-drive head. Designed for direct insertion into bone without predrilling, though predrilling is optional. Used by surgeons in clinical settings for internal fixation of skeletal fractures, osteotomies, and joint fusions. Device provides mechanical stabilization of bone segments to facilitate healing. Marketed as non-sterile, single-use implants requiring steam sterilization by the user.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Metallic bone fixation fastener; 1.5-2.0 mm diameter; cross-drive head; self-drilling tip. Non-sterile; requires steam sterilization. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for surgeons to stabilize and fixate oral, cranio-maxillofacial, and small bones of the hand, feet, wrist, ankles, fingers, and toes; used for osteotomies, revision procedures, joint fusion, and reconstructive procedures.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes 1.3MM Self Drilling Screw (K983485)
• Osteomed Corp. Auto-Drive Bone Screw (K974785)
• KLS Martin L.P. Centre-Drive Drill Free Screw (K971297)

Submission Summary (Full Text)

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013954

## Summary of Safety and Effectiveness

FEB 2 8 2002

Lorenz Self Drilling Screw Device Name:

Screw, Fixation, Bone Classification Name:

87HWC (21 CFR 888.3040) Device Product Code:

### Intended Use:

Internal fixation devices to aid the surgeon in the stabilization and fixation of oral micinal "itsanon" do recess" to "all bones of the hand, feet, wrist, ankles, fingers and toes, Craino-maximonomics, osteotomies, revision procedures, joint fusion and reconstructive procedures.

### Description:

The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up The son urining become are the we ar cross drive. The tip of the screw is designed so that a predrilled hole is not required, but may be used.

#### Sterility Information:

The Lorenz Self Drilling Screws will be marketed as non-sterile, single use devices. Steam Sterilization recommendations are included in the package insert and can be seen in Attachment I.

### Substantial Equivalence:

Walter Lorenz considers the Lorenz Self Drilling Screws equivalent to Synthes 1.3MM Self C Drilling Screw (K983485), Osteomed Corp. Auto-Drive Bone Screw (K974785), and KLS TAB 3 includes a substantial Martin L.P. Centre-Drive Drill Free Screw (K971297). equivalence comparison table to competitive devices. TAB 4 includes sales information and/or Premarket clearance (510K) for Synthes, Osteomed Corp. and KLS Martin L.P.

### Possible risks:

- 1. Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening of the device.
- 2. Nonunion or delayed union which may lead to breakage of the implant.
- 3. Migration, bending, fracture or loosening of the implant
- 4. Metal sensitivity, or allergic reaction to a foreign body.
- 5. Decrease in bone density due to stress shielding.

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K013954/

- 6. Pain, discomfort, abnormal sensation, or palpability due to the presence of the device.
- 7. Increased fibrous tissue response around the fracture site and/or the implant.
- 8. Necrosis of bone.
- 9. Inadequate healing.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2002

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

Re: K013954

Trade/Device Name: Lorenz Self Drilling Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 29, 2001 Received: November 30, 2001

Dear Ms. Reed:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section >10(x) premail.com substantially equivalent (for the indications felerenced above and nave ucterimined in asketed predicate devices marketed in interstate for use stated in the encrosule) to regarly manatical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Ecderal Food - Frye commerce prior to May 28, 1976, the enaomines with the provisions of the Federal Food, Drug, devices that have been recassinou in accessfire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approva You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the devices, belyer to the many al registration, listing of general controls provisions of the 120 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 If your device is classified (500 above) into existing major regulations affecting your device can may be subject to such additional controller and the may of the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouchasing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issualled of a backed on the other requirements of the Act that IDA has made a dolorimizations administered by other Federal agencies. You must or ally Federal statures and regulations administration of registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as school collection in the closed CFK Fall 807), labeling (21 CFR Part 800), good that if applicable. the clectronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if application (200 forth in the quality systems (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) I his letter will anow you to begin manisting of substantial equivalence of your device to a legally premarket nothication. The PDA miding of basification 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 If you desire specific advice for your acvitro diagnostic devices), please contact the Office of additionally 21 CFN Part 607.10 for mirrate untile promotion and advertising of Compliance at [phone]. Tuditionally 10 quest 1001) 594-4639. Also, please note the your device, prease comate and of eference to premarket notifications of (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the nex Other general information on your responsibilities under the Act may be obtained from the Other general information on your respentional 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,

L. Muh A. Milkeron

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:** k(0)3954/

Device Name: Lorenz Self Drilling Screw

### Indications For Use:

Internal fixation devices to aid the surgeon in the stabilization and fixation of oral toes cranio-maxillofacial skeletal bone, small bones of the hand, feet, wrist, ankles, finages and toes, cranio-maxilional skeicial bone, amall oches or and and reconstructive procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Mark H. Millman

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

510(k) Number K013954

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