REFIX INTERNAL FRACTURE FIXATION SCREWS

K050388 · Xtremi-T, LLC · HWC · Sep 7, 2005 · Orthopedic

Device Facts

• Record ID: K050388
• Device Name: REFIX INTERNAL FRACTURE FIXATION SCREWS
• Applicant: Xtremi-T, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Sep 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing bone fragments. For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.

Device Story

ReFIX Internal Fixation Screws are biodegradable polymer devices used for bone fragment fixation and alignment. Manufactured from PLLA and PLGA; available in diameters 2.7mm–6.0mm and lengths 30mm–60mm. Used intraoperatively by surgeons to stabilize non-load bearing bone fractures, osteotomies, and arthrodeses. Screws are sized and trimmed during surgery using specialized instrumentation. Device provides mechanical stabilization of bone fragments to facilitate healing; biodegradable nature eliminates need for secondary removal surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: PLLA and PLGA biodegradable polymers. Form factor: Threaded screws, 2.7mm–6.0mm diameter, 30mm–60mm length. Principle: Internal bone fixation/alignment. Sterilization: Not specified.

Indications for Use

Indicated for fixation/alignment of non-load bearing bone fractures, osteotomies, and arthrodeses, including apical, osteochondral, and cancellous fragments. Specific applications include fractures of ankle, colles, distal radius, hand/wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges, radial head; fusions of metacarpals, metatarsals, phalanges; and hallux valgus correction.

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

• TRIMIT (K041189)
• Reunite Screw (K992301)
• Bonescrew (K964970)
• Smartscrew (K042295)
• Nugen FX (K032447)
• Nugen FX (K023022)
• Smartscrew (K012001)
• Smartscrew (K003077)
• Smartscrew (K992947)
• Distal Radius Screw (K974876)
• OTPS System (K030900)
• OTPS System (K023887)

Submission Summary (Full Text)

{0}------------------------------------------------

page 1/2

# SEP - 7 2005

# 510(K) SUMMARY

# Subject 510(k) Number K050388

### Sponsor

# Xtremi-T, LLC

3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, New Jersey 08648

## FDA Establishment Registration Number

3004613836

## Official Contact

Shawn T. Huxel, President Xtremi-T, LLC 3131 Princeton Pike; Bldg 5, Suite 200 Lawrenceville, New Jersey 08648 Phone - [phone] Fax - [phone] Mobile - [phone]

### Proprietary Name

ReFIX™ Internal Fixation Screws

#### Common Name

Biodegradable Internal Fixation Device

## Classification Name and Reference

888.3040 - Smooth or Threaded Bone Fixation Fastener

Regulatory Class Class II

# Device Product Code

(Panel 87) HWC

### Date Prepared 25 April, 2005

Xtremi-T, LLC

{1}------------------------------------------------

page 2 of 2

#### Brief Description of Device

ReFIX™ Screws are comprised of Internal Fracture Fixation Devices based upon biodegradable polymer fixation systems. Biodegradable polymers are widely used in the orthopaedic specialty. The ReFIX Screws are manufactured from PLLA and PLGA. The Screws are available in diameters ranging from 2.7mm to 6.0mm. ReFIX Screws are available in lengths ranging from 30mm to 60mm. The Screws are sized and trimmed intraoperatively using the ReFIX instrumentation according to the surgical technique. The sizes and materials are designed to address the indications cited.

#### Indications for Use

ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments cancellous/non-load bearing bone fragments.

For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.

#### Basis for Substantial Equivalence

The substantial equivalence of the ReFIX Screws is based on the equivalence in intended use, materials, operational principals, and indications to:

| DEVICE | Manufacturer | Trade Name |
|---------|--------------|---------------------|
| K041189 | Arthrex | TRIMIT |
| K992301 | Biomet | Reunite Screw |
| K964970 | Biomet | Bonescrew |
| K042295 | Bionx | Smartscrew |
| K032447 | Bionx | Nugen FX |
| K023022 | Bionx | Nugen FX |
| K012001 | Bionx | Smartscrew |
| K003077 | Bionx | Smartscrew |
| K992947 | Bionx | Smartscrew |
| K974876 | Bionx | Distal Radius Screw |
| K030900 | Inion | OTPS System |
| K023887 | Inion | OTPS System |

#### END OF 510(K) SUMMARY

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2005

Mr. Shawn T. Huxel President Xtremi-T, LLC 3131 Princeton Pike Building 5, Suite 200 Lawrenceville, New Jersey 08648

Re: K050388

Trade/Device Name: ReFIX™ Internal Fracture Fixation Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 18, 2005 Received: July 19, 2005

Dear Mr. Huxel:

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

{3}------------------------------------------------

Page 2-Mr. Shawn T. Huxel

This letter will allow you to begin marketing your device as described in your Section 510(k) Fins lotter will and in your to FDA finding of substantial equivalence of your device to a legally premaired 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 in you attire 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 other generals, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Signature

Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Statement of Indications for Use

510 (K) NUMBER IF KNOWN: K050388 MANUFACTURER: Xtremi-T, LLC DEVICE NAME: ReFIX Internal Fracture Fixation Screws

Indications:

ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing bone fragments.

For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

**Prescription Use**
(Per 21 CFR 801.109)

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

**510(k) Number** C050388

Xtremi-T, LLC

**Over-the-Counter Use**
(Optional Format 1, 2, 100C)

(Optional Format 1-2-1996)

Confidential