IP-XS COMPRESSION NAIL SYSTEM

K032548 · Plus Orthopedics · HSB · Sep 10, 2003 · Orthopedic

Device Facts

• Record ID: K032548
• Device Name: IP-XS COMPRESSION NAIL SYSTEM
• Applicant: Plus Orthopedics
• Product Code: HSB · Orthopedic
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.

Device Story

IP-XS Compression Nail System; intramedullary nail for small bones. Diameters 3.5mm and 4.5mm; circular cross-section; multiple transverse holes for interlocking. Proximal holes elongated for axial movement to apply bone compression; internal axial threaded hole for compression screw. Interlocking components: 2.0mm and 1.6mm threaded Kirschner wires. Used by surgeons in clinical settings for fracture fixation, osteotomy, or arthrodesis. Provides mechanical stabilization of bone fragments; compression screw allows active compression across fracture site. Benefits include improved alignment and stability for small bone healing.

Clinical Evidence

Bench testing only. Testing included cantilever loading simulating ankle fracture applications and validated Finite Element Analysis (FEA) to confirm the device supports expected in-vivo loads.

Technological Characteristics

Intramedullary nail; 3.5mm and 4.5mm diameters; circular cross-section; stainless steel or titanium (implied by orthopedic standard); mechanical fixation via interlocking Kirschner wires (2.0mm/1.6mm) and compression screw. Standalone mechanical device.

Indications for Use

Indicated for patients requiring alignment, stabilization, and fixation of long bone fractures (trauma or disease), fixation of osteotomies, or arthrodesis.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Small Bone Nail (Accumed K031438)
• SST Small Bone Locking Nail (Biomet)

Submission Summary (Full Text)

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Date August 14, 2003

Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121

Contact person

J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199

Common name Intramedullary nail

# Classification name

Rod, Fixation, Intramedullary and Accessories per 21 CFR section 888.3020.

### Equivalent Device

The IP-XS Compression Nail is similar in materials, design and indications as the Small Bone Nail (Accumed K031438) and SST Small Bone Locking Nail (Biomet).

### Device Description

The IP-XS Compression Nail system is for bones with small comes in diameters of 3.5mm and 4.5mm. They have a circular cross section with multiple transverse holes for interlocking components. The two proximal transverse holes are elongated to allow the interlocking component to move axially and apply compression to the bone fragments. The proximal end has an internal axial threaded hole to receive a compression screw. Threaded Kirschner wires 02.0mm and 01.6mm are used as the interlocking components.

# Intended Use

The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.

#### Summary Nonclinical Tests

Cantilever testing, simulating loading that might be seen when this device is used for ankle fractures, was performed as well as validated FEA analysis. This testing indicates that the IP-XS Compression Nail will support the in-vivo loads expected to be seen for this application.

SEP 1 0 2003

K032548
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Mr. J.D. Webb PLUS Orthopedics 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K032548

Trade/Device Name: IP-XS Compression Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 14, 2003 Received: August 18, 2003

Dear Mr. Webb:

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.

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Page 2 - Mr. J.D. Webb

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), please contact the Office 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 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 yours,

Miriam C. Provost

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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510(k) number (if known): K0 305 4 8

Device Name:

Indications for Use:

# IP-XS Compression Nail System Indications for Use

The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

Prescription Use (per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional format 1-2-96)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number_KO32548