LOCON VLS DISTAL RADIUS PLATE SYSTEM

K042358 · Wrightmedicaltechnologyinc · KTT · Oct 7, 2004 · Orthopedic

Device Facts

• Record ID: K042358
• Device Name: LOCON VLS DISTAL RADIUS PLATE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KTT · Orthopedic
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable: - Joint destruction and/or subluxation visible on x-ray; . - Failed fracture fixation with or without bone graft; . - Osteotomy and repair of distal radius malunion with or without bone graft; . - Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone; - Volar plates are indicated for use with comminuted articular fractures, shearing fractures . of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator; - Locking volar plates are indicated for use with volar articular shearing fractures .

Device Story

LOCON™ VLS Distal Radius Plate system provides internal bone fixation for distal radius fractures. System comprises stainless steel plates (standard/long, left/right configurations) with locking/non-locking screw holes, cortical screws, and cancellous screws (standard/locking). Plates feature cupped heads to accommodate patient anatomy and K-wire holes for temporary fixation. Used by orthopedic surgeons in clinical/surgical settings to stabilize fractures, facilitate bone healing, and restore joint alignment. Device provides mechanical support to bone fragments, preventing displacement and promoting union. Benefits include improved fracture stability compared to non-operative management or percutaneous pinning, particularly in comminuted or shearing fracture patterns.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by design, material, and analysis data.

Technological Characteristics

Stainless steel bone fixation plates and screws. Plates include locking and non-locking holes, compression slots, and K-wire holes. Cortical screws (3.5mm diameter) and cancellous screws (2.7mm diameter, standard and locking). Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for patients with unstable distal radial fractures where closed reduction is unsuitable, including joint destruction/subluxation, failed prior fixation, malunion requiring osteotomy, and displaced/non-displaced fractures with or without fragmentation. Specific indications include comminuted articular fractures, shearing articular fractures, severely comminuted extra-articular fractures, and fractures with loss of reduction post-percutaneous pinning.

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.

Predicate Devices

• LOCON-T® Distal Radial Plate System

Submission Summary (Full Text)

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K 042358

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the LOCON™ VLS Distal Radius Plate.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|---------------------------------------------------|
| Date: | August 30, 2004 |
| Contact Person: | Jeanine H. Redden |
| | Regulatory Affairs Specialist II |
| Proprietary Name: | LOCONTM VLS Distal Radius Plate |
| Common Name: | Volar Plate |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone -- Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3030 Plate, Fixation, Bone -- Class II |

### DEVICE INFORMATION

#### A. INTENDED USE

The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable:

- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- Volar plates are indicated for use with comminuted articular fractures, shearing fractures . of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator;
- Locking volar plates are indicated for use with volar articular shearing fractures .

### B. DEVICE DESCRIPTION

The LOCON™ VLS Distal Radius Plate System consists of plates, cortical screws, and cancellous screws. The design features of the plates and screw components are summarized ﻨﻮ ・・・・・・・ below:

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## Plates

- Manufactured from stainless steel .
- Offered in two lengths: Standard and Long .
- Left and right configurations .
- Locking and non-locking screw holes in distal portion .
- Cortical screw holes located in proximal portion .
- Compression slot feature in proximal portion .
- K-wire holes in head and shaft t
- Cupped head with varying arch to accommodate patient's anatomy .

## Cortical Screws

- Manufactured from stainless steel .
- Available with 3.5mm diameter in lengths from 12mm- 20mm .

Cancellous Screws

- Manufactured from stainless steel .
- Available in two designs: standard and locking .
- Standard screws are available with 2.7mm diameter in lengths from 12 26mm in 2mm . increments
- Locking screws are available with 2.7mm diameter in lengths from 14 26mm in 2mm t increments

# C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the LOCON™M VLS Distal Radius Plate System are substantially equivalent to the LOCON-T® Distal Radial Plate System. The fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the LOCON™ VLS Distal Radius Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UC1 ? ~ 2004

Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K042358 Trade/Device Name: LOCON™ VLS Distal Radius Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: August 30, 2004 Received: September 13, 2004

Dear Ms. Redden:

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. Jeanine H. Redden

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyourse FDA finding of substantial equivalence of your device to a legally practed 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), please contact the Office of Compliance 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 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 yours,

Mark A. Milken

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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# Indications for Use

510(k) Number (if known):

Device Name: LOCON™ VLS Distal Radius Plate

Indications For Use:

The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable:

- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- Volar plates are indicated for use with comminuted articular fractures, shearing . fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator;
- Locking volar plates are indicated for use with volar articular shearing fractures .

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)

Mark A. Milburn

of General. Restorative,

and Neurologica. Devices

510(k) Number

K042358

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