LIGAMENTOTAXOR

K094043 · Arex USA · HTY · Aug 17, 2010 · Orthopedic

Device Facts

• Record ID: K094043
• Device Name: LIGAMENTOTAXOR
• Applicant: Arex USA
• Product Code: HTY · Orthopedic
• Decision Date: Aug 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

Device Story

The AREX Ligamentotaxor (LTX) is an external fixation system for the proximal interphalangeal (PIP) joint. It is used by surgeons to treat complex fracture dislocations, stable/unstable dislocations, fracture luxations, and pilon fractures. The device provides external distraction to the joint, facilitating healing. It is applied in a clinical/surgical setting. The system may be used alone or in conjunction with additional pins, screws, or tendon repair. Clinical outcomes, including range of motion, pain (VAS scale), and patient satisfaction, are monitored by the physician to assess healing and functional recovery. The device benefits patients by stabilizing the joint and allowing for controlled distraction during the healing process.

Clinical Evidence

Multicenter study across 10 sites in 4 countries (n=83 cases). Patients (ages 17-89) treated for PIP fractures/dislocations. Mean follow-up 15.2 months. Endpoints included fracture healing, range of motion, pain (VAS), DASH scores, and adverse events. All fractures healed. Adverse events (e.g., residual pain, subluxations, infections) were comparable to literature for predicate devices. Outcomes for pain, function, and satisfaction were similar to predicates.

Technological Characteristics

External fixation system for PIP joint. Materials, design, and distraction force parameters are similar to predicate devices. No new materials or technologies employed. Mechanical distraction principle.

Indications for Use

Indicated for treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures of the PIP joint in patients requiring external fixation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• BioSymetRic external fixator (K980370)
• Compass System (K970713)

Submission Summary (Full Text)

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长094043

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# PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)

AUG 1 7 2010

# Date of Preparation: July 26, 2010

| Applicant: | AREX USA LLC<br>1335 Merrybrook Rd<br>Collegeville, PA 19403 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Individual: | Ellen Hokanson, President<br>610-584-6870 |
| Trade Name: | AREX Ligamentotaxor (LTX) |
| Common Name: | PIP Joint External Distraction Device |
| Regulation Number: | 888.3040 |
| Product Code: | HTY |
| Classification Name: | Pin, Fixation, Smooth |
| Classification: | Class II |
| Predicate Device Name: | BioSymetRic external fixator (K980370) marketed by<br>Biomet Inc and the Compass System (K970713) of Smith<br>and Nephew |
| Device Description: | The Ligamentotaxor is an external fixation system intended<br>for use in the treatment of complex fracture dislocations,<br>stable and unstable dislocations, fracture luxations, and<br>pilon fractures in the PIP joint. |

The External Fixation System is as follows:

| Description | Reference |
|----------------|-----------|
| Ligamentotaxor | LTX |

The Ligamentotaxor is an external fixation system intended for Intended Use: use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

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### Technology:

The fundamental scientific technology of the Arex Ligamentotaxor is substantially equivalent to the identified predicate device.

## Substantial Equivalence:

The materials, design, and indications for use of the AREX Ligamentotaxor are similar to the identified predicate devices. In addition, distraction force testing of the Ligamentotaxor was performed; and, clinical data was provided to demonstrate outcomes similar to those of the identified predicate devices. No new technology or materials have been employed in the design.

To summarize the clinical data, the Ligamentotaxor was evaluated in a 10 site multicenter study in 4 countries. The device was used to treat 83 cases with various fractures and dislocations of the PIP. In 60 cases the Ligamentotaxor alone was used, other patients received additional tendon repair and/or osteosynthesis with additional pins or screws. There were 16 females and 67 males treated whose ages ranged from 17 to 89 years. The Ligamentotaxor was left in place for an average of 36 days. The mean follow-up for the patients was 15.2 months, ranging from 6 months to 38 months. For each patient, age, gender, mechanism of injury, dominant/non-dominant hand, Pelissier fracture class, duration of treatment, any further treatment, mode of rehabilitation, adverse events, flexion/extension range of motion, finger/thumb mobility, pain using the VAS 10 point scale, the quick DASH, job status, and patient satisfaction were reported and evaluated. Types of adverse events included mild or intermittent residual pain often triggered during exercise or cold, secondary subluxations, superficial infections, clinodactyly, two patients had stiff and painful fingers that led to fusion surgery, one patient had a completely stiff finger, and there were 2 swan neck deformations. One patient with diabetes mellitus, osteoarthritis resulted in a premature removal of the system at 18 days. It was reported that all fractures healed. Types and rates of adverse events compared favorably with types and rates reported in the literature for the predicate devices. Outcomes for pain, function, and patient satisfaction were also similar to those reported in the literature for the predicate devices and demonstrate the safety and efficacy of the Ligamentotaxor. The AREX Ligamentotaxor presents no new issues regarding safety and effectiveness as compared to legally marketed predicate devices.

7/26
/10

Ellen Hokanson Date President

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Arex USA LLC % Ms. Ellen Hokanson President 1335 Merrybrook Road Collegeville, Pennsylvania 19403

AUG 1 7 2010

Re: K094043

Trade/Device Name: AREX Ligamentotaxor (LTX) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: August 13, 2010 Received: August 16, 2010

Dear Ms. Hokanson: -

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Ms. Ellen Hokanson

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Barbara Bneher

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K094043

# Indications for Use

510(k) Number: K094043

Device Name:

AREX USA Ligamentotaxor (LTX)

Indications for Use:

The Ligamentotaxor is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.

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)

Smitu for mxm
(Division Sign-Off)

Division of Surgical Orthopedic, and Restorative Devices

510(k) Number K094043