REPROCESSED EXTERNAL FIXATION DEVICE

K083636 · Sterilmed, Inc. · KTT · Mar 2, 2009 · Orthopedic

Device Facts

• Record ID: K083636
• Device Name: REPROCESSED EXTERNAL FIXATION DEVICE
• Applicant: Sterilmed, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Mar 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Post-traumatic joint contracture which has resulted in loss of range of motion: fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities: correction of segmental bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions and management of comminuted intra-articular fractures of the distal radius.

Device Story

Reprocessed external fixation device consisting of bridge elements (rods, articulating/telescoping components) and connection elements (rings, plates, posts). Device functions as mechanical support for bone stabilization/distraction. Used in clinical settings by physicians for orthopedic applications. Reprocessing involves cleaning and functional validation of original manufacturer components. Some components are MR safe. Anchorage pins and wires excluded from scope. Output is mechanical stabilization of bone segments; aids in fracture healing, deformity correction, and limb lengthening.

Clinical Evidence

Bench testing only. Functional testing of representative reprocessed constructs and process validation of cleaning procedures performed to demonstrate safety and effectiveness.

Technological Characteristics

Metallic bone fixation components (rods, rings, plates, posts). Includes MR safe non-magnetic materials. Mechanical assembly. No software or electronic components.

Indications for Use

Indicated for patients requiring external fixation for post-traumatic joint contracture, fractures, pseudoarthrosis of long bones, limb lengthening, correction of bony/soft tissue deformities or defects, joint arthrodesis, infected fractures/nonunions, and comminuted intra-articular distal radius fractures.

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

• Smith & Nephew Original Ilizarov® External Fixation System

Submission Summary (Full Text)

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K083636 (pg 1/1)

**STERILMED, INC.**
*Sterile & Disposable Medical Devices*

A.

National Endowment for Financial Education

510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 8, 2008 For Reprocessed External Fixation Devices

#### SUMMARY AND CERTIFICATION 11.

510(k) Summary

MAR - 2 2009

| Submitter: | SterilMed, Inc. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Garrett Ahlborg<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 763-488-3483<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 8, 2008 |
| Trade Name: | Reprocessed External Fixation device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories. |
| Classification Number: | Class II, 21 CFR 888.3030 |
| Product Code: | KTT |

| Predicate<br>Device: | The reprocessed external fixation device is substantially equivalent to the Smith & Nephew<br>Original Ilizarov® External Fixation System. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed's reprocessed external fixation devices consist of the standard bridge elements (rods,<br>articulating and telescoping components), and connection elements (rings, plates, and posts)<br>contained in the original manufacturer's system. Some of the components are MR safe and<br>made of non-magnetic materials. MR safe components are intended for use in the MR<br>environment.<br>Note: Only the non-patient contact, external frame elements are the subject of this submission,<br>the anchorage pins and wire elements are not included in the scope of this submission |
| Intended Use: | Post-traumatic joint contracture which has resulted in loss of range of motion: fractures and<br>disease which generally may result in joint contractures or loss of range of motion and fractures<br>requiring distraction: open and closed fracture fixation; pseudoarthrosis of long bones; limb<br>lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue<br>deformities: correction of segmental bony or soft tissue defects; joint arthrodesis; infected<br>fractures or nonunions and management of comminuted intra-articular fractures of the distal<br>radius. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed external fixation constructs were tested to demonstrate<br>appropriate functional characteristics. Process validation testing was performed to validate the<br>cleaning procedure. In addition, the manufacturing process includes visual and validated<br>functional testing of all products produced. |
| Conclusion: | The Reprocessed External Fixation Devices are substantially equivalent to the Smith &<br>Nephew Original Ilizarov® external fixation devices.<br>This conclusion is based upon the devices` similarities in functional design (principle of<br>operation), materials, indications for use and methods of construction. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed, Inc. % Mr. Garrett Ahlborg Regulatory Affairs Specialist 11400 73rd Ave. North #100 Maple Grove, Minnesota 55369

MAR - 2 2009

Re: K083636

Trade/Device Name: Reprocessed External Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: December 8, 2008 Received: December 9, 2008

Dear Mr. Ahlborg:

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, ilisting 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 100-1000.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

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

Enclosure

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# Indications for Use

510(k) Number (if known): _ K083636

Device Name: Reprocessed External Fixation Device

### Indications for Use:

- Post-traumatic joint contracture which has resulted in loss of range of motion. .
- Fractures and disease which generally may result in joint contractures or loss of range of motion and � fractures requiring distraction.
- Open and closed fracture fixation. .
- Pseudoarthrosis of long bones. �
- Limb lengthening by epiphyseal or metaphyseal distraction. .
- Correction of bony or soft tissue deformities. ●
- Correction of segmental bony or soft tissue defects. .
- Joint arthrodesis.
- Infected fractures or nonunions. .
- Management of comminuted intra-articular fractures of the distal radius.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number 1083631