REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES

K012648 · Alliance Medical Corp. · KTT · Jun 24, 2002 · Orthopedic

Device Facts

• Record ID: K012648
• Device Name: REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
• Applicant: Alliance Medical Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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, and fasteners used for orthopedic fracture management, reconstruction, and deformity correction. These devices are applied by surgeons in clinical settings to provide skeletal stability or traction. The device functions by mechanically stabilizing bone segments or applying traction through the skin. The reprocessed devices are identical in design, materials, and mechanical function to the original manufacturer's devices. They are intended to provide the same rigidity and stability as the predicate devices, facilitating bone healing and structural alignment.

Clinical Evidence

Bench testing only. Performance was demonstrated through laboratory testing, including biocompatibility assessments and validation of the reprocessing protocols to ensure the devices meet original performance specifications.

Technological Characteristics

Metallic alloys, plastics, and composites. Mechanical fixation system comprising frames, clamps, rods, couplings, pins, and fasteners. No changes to original design, materials, or dimensions. Sterilization is performed as part of the reprocessing validation.

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 deformities and segmental 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

• Extended Ball Joint with Rod Hoffmann External Fixation System (K802722)
• Howmedica Mono-Tube™ External Fixation System (K930836)
• Hoffman II Compact External Fixation System (K971755)

Submission Summary (Full Text)

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JUN 2 4 2002

K012648 10F2

# 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 NUMBER | DESCRIPTION |
|--------------|--------------|-----------------------------|
| HOWMEDICA | 3362-1-304 | OMEGA PLUS SIDEPLATE |
| HOWMEDICA | 4920-1-100 | TUBE-TO-ROD CLAMP |
| HOWMEDICA | 4940-1-020 | PIN-TO-ROD CLAMP |
| HOWMEDICA | 4940-1-058 | PIN-TO-ROD CLAMP |
| HOWMEDICA | 5029-1-511 | 5 HOLE LIGHTWEIGHT ALLOY |
| HOWMEDICA | 5029-2-110 | 10 HOLE LIGHTWEIGHT |
| HOWMEDICA | 5029-2-111 | 10 HOLE LIGHTWEIGHT ALLOY |
| HOWMEDICA | 5029-8-200 | STEEL ROD |
| HOWMEDICA | 5029-8-250 | STEEL ROD |
| HOWMEDICA | 5029-8-300 | STEEL ROD |
| HOWMEDICA | 5029-8-825 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-835 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-840 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-845 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-850 | CARBON FIBER ROD |
| HOWMEDICA | 5049-3-032 | ARTICULATION COUPLING |
| HOWMEDICA | 5150-2-380 | CARBON FIBER ROD |
| HOWMEDICA | 5150-2-391 | CARBON TUBE |
| HOWMEDICA | 5150-3-065 | EXTERNAL FIXATION PIN CLAMP |
| HOWMEDICA | 5151-3-065 | EXTERNAL FIXATION PIN CLAMP |

:

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K012648
20F2

| Predicate device(s): | K802722 | Extended Ball Joint with Rod Hoffmann External<br>Fixation System | | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------|----------|--------------------|
| | K930836 | Howmedica | Mono-Tube™ | External | Fixation<br>System |
| | K971755 | Hoffman II Compact External Fixation System | | | |
| 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 used<br>for the management of bone fractures and reconstructive, as well as<br>corrective, orthopedic surgery. Materials used include metal alloys,<br>plastic and composites. These materials are chosen to address a wide<br>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 or<br>traction may be applied to the skeletal system; and others may be used<br>for fixation of bone fractures, for bone reconstructions, as a guide pin<br>for insertion of other implants, or it may be implanted through the skin<br>so that a pulling force (traction) may be applied to the skeletal system. | | | | |
| Indications statement: | Reprocessed external fixation devices are indicated for use in patients<br>requiring external skeletal fixation oand treatment of fractures,<br>osteotomy, arthrodesis, correction of deformities, fracture revision,<br>bone reconstruction procedures, limb lengthening, correction of bony<br>or soft tissue deformities and segmental bony or 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. | | | | |
| | Biocompatibility | | | | |
| | Validation of reprocessing | | | | |
| | 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. | | | | |

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above and below them.

#### 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 . SEM 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,

Marke McMullens

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

#### K012648 510(k) Number (if known):

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.

Mark N Milkerson

(Division Sign-Off) 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)

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

CONFIDENTIAL

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