A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM

K042458 · A.M. Surgical, Inc. · LXT · Oct 7, 2004 · Orthopedic

Device Facts

• Record ID: K042458
• Device Name: A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
• Applicant: A.M. Surgical, Inc.
• Product Code: LXT · Orthopedic
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.

Device Story

External wrist fixator; titanium construction; consists of two connecting slide sections (distal and proximal) with predetermined angled holes. Operates by inserting standard Kirschner wires (K-wires) through angled holes into bone for fracture fixation; three wires in distal section, two in proximal. Sections adjustable distal to proximal; locked via center hex screw. Used by surgeons in clinical settings for fracture stabilization. Provides rigid external support to facilitate healing when soft tissue condition prevents standard casting or internal fixation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium external fixator; two-section sliding frame; utilizes standard Kirschner wires (K-wires) for bone fixation; center hex screw locking mechanism; sterile; single-use.

Indications for Use

Indicated for external stabilization of open and/or unstable distal radius fractures in patients where soft tissue injury precludes alternative treatments like IM rodding, casting, or other external fixation.

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

• NBX-Non Bridging External Fixator (K020905)

Submission Summary (Full Text)

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## 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is: K042458

#### Submitter's Identification: 1.

A.M. Surqical, Inc 290 East Main Street Suite 200 Smithtown, NY 11787 Tel: [phone] Fax: [phone]

Date Summary Prepared: September 9, 2004

#### 2. Name of the Device:

- Proprietary: A.M. Surgical CPF Distal Radial External Cross Pin Fixation a. System
- Common Name: Multiple Component Metallic External Bone Fixation b. Appliance
- Classification Name: Appliance, Fixation, Nail, Blade, Plate Combination C. Multiple Component, Metal Composite
- ರ. Device Class: 21 CFR 888.3030, Class II
- Classification Panel: Orthopedic છ.
- Product Code: 87 LXT f.

#### 3. Predicate Device Information:

The A.M. Surgical Distal Radial External Cross Pin Fixation System is substantially equivalent in intended use and design to the NBX-Non Bridging External Fixator marketed by Biomet Orthopedics, Inc. under K020905.

#### 4. Device Description:

A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is an external wrist fixator made of titanium , consisting of two (distal and proximal) connecting slide sections with predetermined angled holes. Standard Kirschner wires (K-wire) are inserted through the predetermined angle holes for fracture fixation, three on the distal section and two on the proximal section. The sections can be adjusted distal to proximal and locked into place by way of a center hex screw.

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The device will be offered sterile and is single use.

#### 5. Intended Use:

The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of external fixation.

#### Comparison to Predicate Devices: 6.

The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is identical to the predicate in intended use, and similar in design in that both devices include an external frame on pin or k-wire implants. The device differ in that the predicate is used off the fracture site, while the subject device is used through the fracture site.

#### 7. Conclusions:

The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is substantially eguivalent to the predicate and is safe and effective for it's intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

A.M. Surgical, Inc. C/o Ms. Carolann Kotula mdi Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K042458

Trade/Device Name: A.M. Surgical CPF Distal Radial External Cross Pin Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: September 9, 2004 Received: September 13, 2004

Dear Ms. Kotula:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your see determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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, de noos mat have been 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 I va mayy attors 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 or uny 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. Carolann Kotula

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin mailieming of substantial equivalence of your device to a legally premarket notineation. The PDF intelligstification 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 II you desire specific advice for your ac 110 en other on and the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the regulation e Colliact the Oritor of Compullion and the notification" (21CFR Part 807.97). You may obtain Missuranting by reference to premailsonsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Milliken

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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Attachment 3

# Indications for Use

510(k) Number (if known):

Device Name: A.M. Surgical CPF Distal Radial External Cross Pin Fixation System

### Indications For Use:

The A.M. Surgical CPF Distal Radial External Cross Pin Fixation System is to be used for external stabilization of open and/or unstable fractures of the distal radius were soft tissue injury may preclude the use of other fracture treatments such as IM roding, casting, and other means of external fixation.

Prescription Use X (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 N. Millerson

neral, Restorative. and Neurological Devices

**510(k) Number** K092458