VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES

K053051 · Vanguard Medical Concepts, Inc. · KTT · Dec 22, 2005 · Orthopedic

Device Facts

• Record ID: K053051
• Device Name: VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
• Applicant: Vanguard Medical Concepts, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Device Story

Vanguard Reprocessed External Fixation Devices are previously used, noninvasive orthopedic components cleaned, inspected, tested, and packaged for reuse. System consists of straight/telescoping rods, rod-to-rod couplings, and rod-to-pin couplings/clamps. Used by surgeons in clinical settings to create rigid bridge constructs for bone stabilization where soft tissue injury precludes internal fixation (e.g., IM rods). Components connect anchoring pins and screws to immobilize bone. Provided non-sterile for steam sterilization by healthcare facility. Reprocessing restores device to OEM specifications, providing a framework for fracture management and bone healing.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Components include rods, telescoping rods, and clamps constructed from stainless steel, carbon fiber, aluminum alloys, or titanium alloys. Mechanical fixation via rod-to-rod or rod-to-pin coupling. Non-sterile; steam sterilization required by user. No software or electronic components.

Indications for Use

Indicated for patients requiring external skeletal traction or fixation for bone conditions including osteotomy, arthrodesis, fracture, and reconstructive surgery. Contraindicated in patients with mental or neurologic impairment interfering with cooperative postoperative care; not for spinal screw attachment or fixation.

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

• Orthofix Radiolucent Wrist Fixator (K053051)

Submission Summary (Full Text)

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K053051 (pg 1 of

# 510(k) Summary of Safety & Effectiveness

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| Submitter | Vanguard Medical Concepts, Inc.<br>5307 Great Oak Drive<br>Lakeland, FL 33815 | DEC 2 2 2005 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact | Trish Stephens<br>Project Manager, Research & Development<br>863-683-8680 ext. 252 [voice]<br>863-904-1604 [facsimile]<br>[e-mail] [email] | |
| Date | October 26, 2005 | |
| Device | Trade Name: Vanguard Reprocessed External Fixation Devices <ul><li>Orthofix Radiolucent Wrist Fixator</li></ul> Common Name: Reprocessed External Fixation Devices Classification: 21 CFR 888.3030 Classification Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Product Code: KTT – Class II | |
| Predicate Devices | External Fixation Devices legally marketed by the following original equipment manufacturer: | |

| Manufacturer | Trade Name |
|----------------|------------------------------------|
| Orthofix, Inc. | Orthofix Radiolucent Wrist Fixator |

| Indications for Use | Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery. | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Contraindications | <ul><li>External Fixation Devices are contraindicated in patients with mental or neurologic impairment that would interfere with cooperative postoperative care.</li><li>These devices are not intended for attachment or fixation of screws to the spine.</li></ul> | |
| | | Continued on next page |

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K053051 (pg 2 of

### 510(k) Summary of Safety & Effectiveness, continued

Device

Vanguard Reprocessed External Fixation Devices are previously used noninvasive orthopedic devices that have been cleaned, inspected, tested, and Description packaged by Vanguard Medical Concepts, Inc. External Fixation Device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation.

> External fixation elements consist of components such as straight rods, telescoping rods, rod-to-rod and pin-to-rod couplings and clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

Rods and Telescoping Rods ~ Straight rods are external fixation devices of varying lengths (adjustable lengths in the case telescoping rods) and diameters that are used with rod-to-rod and pin-to-rod clamps by the surgeon to connect anchoring pins and screws together to form a rigid structure that immobilizes the affected bone or structures. Differences in length and diameter of the rods allow accommodation of a broad range of fracture scenarios and applied loads. All rods have a straight, solid, round design. Rods and telescoping rods are typically constructed of stainless steel, carbon fiber, or aluminum or a combination of materials.

Rod-to-Rod Couplings or Clamps ~ Rod-to-rod couplings or clamps are multi-element components used to connect one rod to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum alloys, steel or stainless steel alloys and titanium alloys.

Continued on next page

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#### KOSBORI 510(k) Summary of Safety & Effectiveness, continued Rod-to-Pin Couplings or Clamps ~ These are multi-clement Device components used to connect one rod or tube to a pin or group of pins in a Description components it ons defined by the individual clamp configuration. They (continued) are designed to interconnect a specific size or range of sizes of rods or tubes to specific sizes or ranges of sizes of pins. The devices are typically constructed from one or more of the following materials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys. Vanguard Reprocessed External Fixation Devices are essentially identical to Technological the Original Equipment Manufacturer (OEM) devices. No changes are made Characteristics to the currently marketed OEM device specifications and the Reprocessed External Fixation Devices possess identical technological characteristics. Cleaning, packaging, and performance testing demonstrate that the Test Data reprocessed devices perform as intended and are safe and effective. and the same of the same of the same of the same of the states of the states of the states of the states of the states of the states Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed External Fixation Devices are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features an eagle-like symbol with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OEC 2 2 2005

Ms. Trish Stephens Project Manager, Research & Development Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, Florida 33815

Re: K053051 Trade/Device Name: Vanguard Reprocessed External Fixation Devices (See enclosed list) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 26, 2005 Received: October 28, 2005

Dear Ms. Stephens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your occurent = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, enerours for togally manivedical 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 approvial of a provisions of the Act. The general controls provisions of the Act include the generats 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 rryour do not additional controls. Existing major regulations affecting your device can be found in the Suble 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 statues and regulations administered by other Federal agencies. You must comply with all the t oderar valiates and registration and listing (21 CFR Part 807); labeling (21 CFR Part 807); labeling (21 Acres requirements money as a 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 - Ms. Stephens

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 the Office of Comphanoo ut (210) 216 021979). You may obtain other general information on reference to premiance the Act from the Division of Small Manufacturers, International and your responsionnes ander the free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Car

Sincerely yours,

Mark N. Malkerson, M.S.

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

Enclosure

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| OEM | Catalog # | Description |
|----------|-----------|--------------------------------|
| Orthofix | 3600A | Radiolucent Wrist Fixator Body |
| | 36008 | Distraction Module |
| | 36017 | Allen Wrench, 4mm |
| | 13620 | Drill Guide |
| | 13621 | Screw Guide |
| | M210 | T-Wrench |

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, ・ Reprocessed External Fixation Device Models found to be Substantially Equivalent:

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### K053051

## Indications for Use

510(k) Number (if known):

Device Name: Vanguard Reprocessed External Fixation Devices

Indications for Use:

Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K053051 |
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|---------------|---------|

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