MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES

K032058 · Alliance Medical Corp. · KTT · Jul 30, 2003 · Orthopedic

Device Facts

• Record ID: K032058
• Device Name: MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
• Applicant: Alliance Medical Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Jul 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

External Fixation Devices are intended to be used for the fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others 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.

Device Story

Reprocessed external fixation devices consist of frames, clamps, rods, couplings, pins, posts, fasteners, wires, bolts, washers, nuts, hinges, and sockets. Used in orthopedic surgery for bone fracture management, reconstruction, and correction. Operates via mechanical stabilization of skeletal system; provides rigidity and traction. Used in clinical settings by surgeons. Device is reprocessed from previously used components; provided non-sterile for hospital-based sterilization prior to use. Benefits include stabilization of fractures and support for reconstructive procedures.

Clinical Evidence

Bench testing only. Validation of reprocessing and functional testing performed to demonstrate that reprocessed devices perform as originally intended.

Technological Characteristics

Materials include metal alloys, plastics, and composites. Mechanical design, shapes, and sizes are identical to predicate devices. Device is provided non-sterile; sterilization performed by the hospital. No software or electronic components.

Indications for Use

Indicated for patients requiring external skeletal fixation for treatment of fractures, osteotomy, arthrodesis, deformity correction, fracture revision, bone reconstruction, limb lengthening, and correction of bony or soft tissue defects.

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

• K012623 Reprocessed Synthes® External Fixation Devices

Submission Summary (Full Text)

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

JUL 3 0 2003

Alliance Medical Corporation

3d058
page 1 of 2

## PART B: 510(k) SUMMARY

| Submitter: | 10232 South 51 ^st Street<br>Phoenix, Arizona 85044 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Moira Barton<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] |
| Date of preparation: | June 11, 2003 |
| Name of device: | Trade/Proprietary Name: Reprocessed External Fixation Devices<br>Common or Usual Name: External Fixation Devices, Fixation Appliance, Single/Multiple Component<br>Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories and Smooth or Threaded Metallic Bone Fixation Fastener |
| Predicate device(s): | K012623 Reprocessed Synthes® External Fixation Devices |
| Device description: | External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and |

Submitter:

s, sockets, connecting bars screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

- External Fixation Devices are intended to be used for the Intended use: fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others 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.

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

page 2 of 2

- Reprocessed external fixation devices are indicated for use in Indications statement: patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
- Technological The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. characteristics: The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. The only change is the modified external fixation devices will be provided non-sterile. Sterilization of the devices will occur in the hospital prior to use.
- Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices.
- Validation of reprocessing ●
- . Function Testing

Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.

- Conclusion: Alliance Medical Corporation concludes that the modified device (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices, as described herein.

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

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized design of an abstract human figure with three wavy lines extending from the figure's head. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 3 0 2003

Ms. Moira Barton Regulatory Affairs Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Re: K032058

Trade/Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 30, 2003 Received: July 2, 2003

Dear Ms. Barton:

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 - Ms. Moira Barton

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,

Mark A. Milliman

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

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

3wo58

## Indications for Use Statement ll.

Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices

Indications for Use: Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milken

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

03 205 8 510(k) Number -

Prescription Use (per 21 CFR 801.109) Over-the-Counter Use