CLEARVIEW WRIST FIXATOR

K020311 · Rigid FX Orthopedics, Incorporated · KTT · Apr 29, 2002 · Orthopedic

Device Facts

• Record ID: K020311
• Device Name: CLEARVIEW WRIST FIXATOR
• Applicant: Rigid FX Orthopedics, Incorporated
• Product Code: KTT · Orthopedic
• Decision Date: Apr 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ClearView Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use: - fractures of the wrist with ligamentous instability . - comminuted intra-articular radius fractures - post-traumatic reconstruction for joint stiffness . - . Colles Fracture - distal radius fractures (Types B and C) ◆ - Frykman Type III, IV, VII and VIII radius fractures ◆ - any wrist fracture requiring distraction

Device Story

ClearView Wrist Fixator is a preassembled, mechanically adjustable external fixator for distal upper extremity fracture management. Device consists of a radiolucent polycarbonate plastic frame applied to bone via 2-3 pairs of self-drilling half-pins. Pins act as bone anchors. Device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Used by surgeons in clinical settings to stabilize wrist fractures, including comminuted intra-articular and Colles fractures. Mechanical distraction and stabilization facilitate bone healing and joint reconstruction. Benefits include rigid fixation and fracture reduction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External fixator; radiolucent polycarbonate plastic frame; 3mm x 110mm self-drilling half-pins made of medical grade stainless steel (316LVM). Mechanically adjustable construct. Available in small, medium, and large sizes.

Indications for Use

Indicated for patients requiring fixation of distal upper extremity fractures, including wrist fractures with ligamentous instability, comminuted intra-articular radius fractures, post-traumatic reconstruction for joint stiffness, Colles fractures, distal radius fractures (Types B and C), Frykman Type III, IV, VII, and VIII radius fractures, and any wrist fracture requiring distraction.

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

• Agee WristJack (K992970)
• Synthes Articulating Distal Radius Fixator (K984498)
• DFS Wrist Fixator (K993649)

Submission Summary (Full Text)

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# APR 2 9 2002

K020311
Page 1 of 1

## Summary of Safety and Effectiveness

Rigid FX Orthopedics, Inc 3601 S. Congress Bldg. B. #300 - Austin, TX 78704 [phone]

Trade Name: ClearView™ Wrist Fixator

Common Name: Wrist Fixator

Classification Name: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030

The device is a preassembled, mechanically adjustable external Device Description: fixator and is available in three sizes (small, medium, and large). It is a four-piece construct consisting of a radiolucent polycarbonate plastic and applied to the bone with 2 pairs, with the option of a third pair, of self-drilling half-pins measuring 3mm x 110mm both cancellous and cortical. The half pins are used as bone anchors and are manufactured from medical grade stainless steel (316LVM).

Intended Use: The ClearView Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use:

- fractures of the wrist with ligamentous instability .
- comminuted intra-articular radius fractures
- post-traumatic reconstruction for joint stiffness .
- . Colles Fracture
- distal radius fractures (Types B and C) ◆
- Frykman Type III, IV, VII and VIII radius fractures ◆
- any wrist fracture requiring distraction

Comparable Features to Predicate Device(s): This device is similar in pin placement, materials, function, and indications to the Agee WristJack marketed by Hand Biomechanics Lab, Inc. (K992970), Synthes Articulating Distal Radius Fixator (K984498) and the DFS Wrist Fixator marketed by EBI/Orthofix (K993649).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of three stylized lines or stripes that are curved and arranged in a way that suggests movement or flow. The seal is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Estrada Vice President of Sales and Marketing Rigid FX Orthopedics, Inc. 3601 S. Congress, Building B, Suite 300 Austin, TX 78704

Re: K020311

Trade/Device Name: ClearView™ Wrist Fixator Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: KTT Dated: January 24, 2002 Received: January 29, 2002

Dear Mr. Estrada:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo no re review a your sectermined the device is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce ass stated in the encreases of the Medical Device Amendments, or to devices that prove to that a sified 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 - Mr. Mark Estrada

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,

Sincerely yours,

Mark N. Milhem

Celia 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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page 1 of 1

KO20311 510(k) Number (if known):

ClearView™ Wrist Fixator Device Name:

-Indications For Use:

### ClearView™ Wrist Fixator Indications For Use

The ClearView™ Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use:

- fractures of the wrist with ligamentous instability .
- comminuted intra-articular radius fractures
- post-traumatic reconstruction for joint stiffness .
- Colles Fracture .
- distal radius fractures (Types B and C) .
- Frykman Type III, IV, VII and VIII radius fractures
- any wrist fracture requiring distraction

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K020311

Prescription Use ) (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)