LORENZ SMALL FRAGMENT SYSTEM

K992961 · Walter Lorenz Surgical, Inc. · HRS · Nov 8, 1999 · Orthopedic

Device Facts

• Record ID: K992961
• Device Name: LORENZ SMALL FRAGMENT SYSTEM
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.

Device Story

Lorenz Small Fragment System comprises titanium bone plates and screws for internal fixation of small bones. Screws range 1.2mm-2.7mm diameter with cross or center drive heads; plates include various geometries (straight, T, L, Y, Z, etc.). Used by surgeons in clinical settings for fracture stabilization, joint fusion, and reconstruction. Device provides mechanical support to bone segments to facilitate healing. Clinical benefit includes restoration of skeletal stability and alignment.

Clinical Evidence

No clinical data provided; device relies on mechanical design and material equivalence to existing bone fixation systems.

Technological Characteristics

Titanium bone plates and screws; screw diameters 1.2mm-2.7mm; cross and center drive head features; various plate geometries including straight, rectangle, parallelogram, trapezoid, T, L, Y, Z, and condylar pin options.

Indications for Use

Indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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## 510(k) Summary

Diana Preston Regulatory Affairs Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218-2480

Device Name: Lorenz Small Fragment System

Common or Usual Name: Small Bone Plating System

Classification Name: Single / Multiple Component Metallic Bone Fixation Appliances and Accessories

Device Classification: Class II

Device Product Code: 87 HRS (21 CFR - 888.3030)

Device Description: The Lorenz Small Fragment System is comprised of a variety of titanium plates and screws with shapes and sizes designed for internal fixation of small bones. The screws will have both cross drive and center drive head features and be 1.2mm - 2.7mm in diameter. The plates will include straight, rectangle, parallelogram, trapezoid, T, L, Y, Z, and condylar pin options with various lengths and thicknesses.

Intended Use: The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.

## Potential Adverse Affects and Complications:

- Poor bone formation, Osteoporosis, Osteomyelitis, inhibited revascularization, or . infection can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Nonunion or delayed union which may lead to breakage of the implant. .
- Migration, bending, fracture or loosening of the implant. .
- . Metal sensitivity, or allergic reaction to a foreign body.
- . Decrease in bone density due to stress shielding.
- Pain, discomfort, or abnormal sensation due to the presence of the device.
- Increased fibrous tissue response around the fracture site and/or the implant.
- Necrosis of bone. •
- . 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/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 1999

Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive 32218 Jacksonville, Florida

K992961 Re : Lorenz Small Fragment System Trade Name: Regulatory Class: II Product Code: HRS September 1, 1999 Dated: Received: "September 2, 1999

Dear Ms. Preston:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਰੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Diana Preston

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): unknown

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Device Name: Lorenz Small Fragment System

- Indications For Use: The Small Fragment System consists of bone plates and screws to be used for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, toes, and craniomaxillofacial skeleton.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative 510(k) Number

Prescription Use_X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)