REPROCESSED EBI EXTERNAL FIXATION DEVICES

K012645 · Alliance Medical Corp. · KTW · Jun 24, 2002 · Orthopedic

Device Facts

• Record ID: K012645
• Device Name: REPROCESSED EBI EXTERNAL FIXATION DEVICES
• Applicant: Alliance Medical Corp.
• Product Code: KTW · Orthopedic
• Decision Date: Jun 24, 2002
• Decision: SESE
• Submission Type: Traditional
• 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, pins, fasteners, and related hardware used in orthopedic surgery. These devices provide rigid skeletal stabilization for fracture management, bone reconstruction, and deformity correction. Operated by surgeons in clinical/OR settings, the devices are applied percutaneously or surgically to stabilize bone segments or provide traction. The reprocessed devices are identical in design, material, and mechanical function to the original predicate devices. They benefit patients by enabling stable bone healing and structural correction.

Clinical Evidence

Bench testing only. Performance testing demonstrated that the reprocessed external fixation devices perform as originally intended. Biocompatibility validation was conducted as part of the reprocessing assessment.

Technological Characteristics

Mechanical external fixation components including frames, clamps, rods, pins, and fasteners. Materials include metal alloys, plastics, and composites. Design, dimensions, and mechanical mechanism are identical to predicate devices. No electronic, software, or energy-based components.

Indications for Use

Indicated for patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, 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

• EBI XFIX® DFS® Rail System (K010437, K951357)
• EBI Small External Fixator (K953406)
• EBI X Fix DynaFix System (K970290)
• EBI X Fix DynaFix Mini External Fixator

Submission Summary (Full Text)

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K012645
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## 510(k) Summary of Safety and Effectiveness

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Don Selvey<br>Vice President, Regulatory Affairs and Quality Assurance<br>[phone] |
| Date of preparation: | 8 August 2001 |
| Name of device: | Reprocessed External Fixation Devices |
| Common Name: | External Fixation Devices, Fixation Appliance, Single/Multiple<br>Component and Invasive Traction Component |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and<br>Accessories |

Reprocessed device(s):

| MANUFACTURER | MODEL<br>NUMBER | DESCRIPTION |
|--------------|-----------------|--------------------------|
| EBI | 01001 | EXTERNAL FIXATOR |
| EBI | 01300 | DFS T-CLAMP |
| EBI | 01520 | STEEL ROD |
| EBI | 03110 | 2 SIDED HEX HEAD WRENCH |
| EBI | 03125 | T-HANDLE HEX HEAD WRENCH |
| EBI | 04300 | DISTAL RADIUS FIXATOR |
| EBI | 13020-EBI | 1/4 STEEL RING |
| EBI | 13035 | 1/4 STEEL RING |
| EBI | 13040 | 3/4 STEEL RING |
| EBI | 1505 | TUBE TO TUBE CLAMP |
| EBI | 2200-EBI | EXTERNAL FIXATOR |
| EBI | 4003 | EXTERNAL FIXATOR |
| EBI | R00096 | EXTERNAL FIXATOR |

Predicate device(s):

EBI XFIX® DFS® Rail System K010437 K951357 EBI Small External Fixator EBI X Fix DynaFix System K953406 K970290 EBI X Fix DynaFix Mini External Fixator

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# KO12645 20 F 2

...

| Device description: | External fixation devices are specially designed frames, clamps, rods,<br>rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation<br>bolts, washers, nuts, hinges, sockets, connecting bars and screws<br>used for the management of bone fractures and reconstructive, as<br>well as corrective, orthopedic surgery. Materials used include metal<br>alloys, plastic and composites. These materials are chosen to address<br>a wide range of fractures and applications as well as to allow for the<br>appropriate amount of rigidity and stability. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use: | External Fixation Devices are intended to be used for the fixation of<br>supracondylar, or condylar fractures of the femur; for fusion of a joint;<br>for surgical procedures that involve cutting the bone, for fixation of<br>bone fractures; bone reconstruction; as a guide pin for insertion of other<br>implants; or may be implanted through the skin so that a pulling force<br>or traction may be applied to the skeletal system; and others may be<br>used for fixation of bone fractures, for bone reconstructions, as a guide<br>pin for insertion of other implants, or it may be implanted through the<br>skin so that a pulling force (traction) may be applied to the skeletal<br>system. |
| Indications statement: | Reprocessed external fixation devices are indicated for use in<br>patients requiring external skeletal fixation oand treatment of<br>fractures, osteotomy, arthrodesis, correction of deformities, fracture<br>revision, bone reconstruction procedures, limb lengthening,<br>correction of bony or soft tissue deformities and segmental bony or<br>soft tissue defects. |
| Technological characteristics: | The design, materials, and intended use of the Reprocessed External<br>Fixation Device s are identical to the predicate devices. The<br>mechanism of action of the Reprocessed External Fixation Device is<br>identical to the predicate devices in that the same standard<br>mechanical design, materials, shapes and sizes are utilized. There are<br>no changes to the claims, intended use, clinical applications, patient<br>population, performance specifications, or method of operation. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate<br>performance (safety and effectiveness) of the Reprocessed External<br>Fixation Devices.<br><br>Biocompatibility Validation of reprocessing<br>Performance testing demonstrates that Reprocessed External Fixation<br>Devices perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21<br>CFR Part 807 and based on the information provided in this<br>premarket notification, Alliance Medical Corporation concludes that<br>the modified device (the Reprocessed External Fixation Device) is<br>safe, effective and substantially equivalent to the predicate devices as<br>described herein. |

r

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 2 4 2002

Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Re: K012623, K012634, K012645, K012648 Trade Name: 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, KTW, JEC Dated: April 3, 2002 Received: April 4, 2002

Dear Mr. Selvey:

We have reviewed your Section 510(k) premarket notifications of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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. Don Selvey

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices . to proceed to the market.

If you desire specific advice for your devices 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 devices, 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 yours,

. Merle N. Millerson

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

Enclósure

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## Indications for Use Statement

510(k) Number (if known):

KO12645

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 oand 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.

| MANUFACTURER | MODEL<br>NUMBER | DESCRIPTION |
|--------------|-----------------|--------------------------|
| EBI | 01001 | EXTERNAL FIXATOR |
| EBI | 01300 | DFS T-CLAMP |
| EBI | 01520 | STEEL ROD |
| EBI | 03110 | 2 SIDED HEX HEAD WRENCH |
| EBI | 03125 | T-HANDLE HEX HEAD WRENCH |
| EBI | 04300 | DISTAL RADIUS FIXATOR |
| EBI | 13020-EBI | 1/4 STEEL RING |
| EBI | 13035 | 1/4 STEEL RING |
| EBI | 13040 | 3/4 STEEL RING |
| EBI | 1505 | TUBE TO TUBE CLAMP |
| EBI | 2200-EBI | EXTERNAL FIXATOR |
| EBI | 4003 | EXTERNAL FIXATOR |
| EBI | R00096 | EXTERNAL FIXATOR |

to Mark N. Milliken

Division of General, Restorative and Neurological Devices

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) CONFIDENTIAL

OL

Over-the-Counter Use

Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)

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