KMI DISTAL VOLAR RADIUS PLATE SYSTEM

K041461 · Kinetikos Medical, Inc. · HRS · Aug 16, 2004 · Orthopedic

Device Facts

• Record ID: K041461
• Device Name: KMI DISTAL VOLAR RADIUS PLATE SYSTEM
• Applicant: Kinetikos Medical, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The use of the KMI Distal Volar Radius Plate is generally indicated for the reduction and fixation of fractures of the distal radius bone. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

Device Story

The KMI Distal Volar Radius Plate System is a metallic bone fixation device used for the reduction, stabilization, and internal fixation of distal radius fractures and osteotomies. The system consists of a titanium plate and two sets of bone screws. It utilizes 'variable angle locking technology' (VALT) to allow for precise angular positioning of screws relative to the plate. The device is intended for surgical use by clinicians to fixate bone fragments, facilitating healing in acute or fresh fractures and non-union cases. It provides mechanical stabilization of the fracture site.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and mechanical design similarities to the predicate device.

Technological Characteristics

Materials: Titanium (Ti-6Al-4V-ELI per ASTM F136). Components: Plate and bone screw sets. Feature: Variable angle locking technology (VALT) for screw positioning. Regulatory Class: II. Product Code: HRS.

Indications for Use

Indicated for reduction, stabilization, and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius. Contraindicated in cases of complete avascular necrosis with inadequate bone stock.

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

• Hand Innovations Distal Volar Radius Fracture Repair System (K002775)

Submission Summary (Full Text)

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# APPENDIX I: SUMMARY OF SAFETY AND EFFECTIVENESS

For

## KMI Distal Volar Radius Plate System

### 1. Submitter:

Kinetikos Medical, Inc. 6005 Hidden Valley Rd. Carlsbad. CA 92009

### Contact Person:

John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road Carlsbad, CA 92009 [phone] FAX [phone]

### Date Prepared: May 29, 2004

- KMI Distal Volar Radius Plate System 2. Trade Name: Distal Volar Radius Fracture Repair System Common Name: Single, multiple component Metallic Bone Fixation Appliances Classification Name: and Accessories, per 888.3030
- Predicate or legally marketed devices which are substantially equivalent 3.

-Hand Innovations Distal Volar Radius Fracture Repair System (K002775)

#### Description of Device 4.

Description device is intended for use in the reduction, stabilization, and internal Fixation of proximal radial bone fractures. The design incorporates the use of a plate and two sets of bone screw sets that are fixated perpendicular. The implant utilizes 'variable angle locking technology' (VALT) screw locking system which facilitates precise angular positioning of the bone screws relative to the distal volar radius plate.

Materials: Titanium; Ti-6A14V-ELI as per ASTM F136

Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.

### 5. Intended Use

The use of the KMI Distal Volar Radius Plate is generally indicated for the reduction and fixation of fractures of the distal radius bone. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

- Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:
There are no significant differences between the KMI Distal Volar Radius Plate and other systems currently being marketed which would adversely affect the use of the product. The KMI Distal Volar Radius Plate employs the same basic mechanical features as the predicate, legally marketed device specified in section I in that the essential configuration consists of a plate and sets of bone screws intended for use in the reduction of fractures of the distal proximal radius bone.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John G. Spampinato Vice President, Quality Assurance Kinetikos Medical, Inc 6005 Hidden Valley Road Carlsbad, California 92009

Re: K041461

Trade/Device Name: KMI Distal Volar Radius Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 29, 2004 Received: June 2, 2004

Dear Mr. Spampinato:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premained is substantially equivalent (for the indications ferenced above and nave acterimined and marketed predicate devices marketed in interstate for use stated in the encrosale) to regary regary the Medical Device Amendments, or to continered price to May 20, 1978, the exactions of the Federal Food, Drug, devices mat nave been recuire approval of a premarket approval application (PMA). alle Cosmetic Act (110) that to her request to the general controls provisions of the Act. The r ou may, merelore, mance of the Act include requirements for annual registration, listing of general controls provisions proctice, 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 elassified (vor a controls. Existing major regulations affecting your device can may be subject to suen additions. Title 21, Parts 800 to 898. In addition, FDA may be found in the OUD acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least be advised that I Drivination that your device complies with other requirements of the Act that I Dri has made a astad regulations administered by other Federal agencies. You must of any Federal statutes and regulations and admited to: registration and listing (21 comply with an the 11ct 621 CFR Part 801); good manufacturing practice requirements as set CT N Fart 607); adomig (DT CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John G. Spampinato

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDF miding of cation 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 acvice for Jour ac [phone]. Also, please note the regulation entitled, Colliact the Office of Comphaliso at (537) 777 Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Mikkelsen

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):_K041461

Device Name: KMI Distal Volar Radius Plate

Indications For Use:

The KMI Distal Volar Radius Plate is generally indicated for the reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.

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)

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vision of General, Restorative,

Wological Devices

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