REPROCESSED EXTERNAL FIXATION DEVICE
Device Facts
| Record ID | K061759 |
|---|---|
| Device Name | REPROCESSED EXTERNAL FIXATION DEVICE |
| Applicant | Ascent Healthcare Solutions |
| Product Code | KTT · Orthopedic |
| Decision Date | Sep 5, 2006 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Zimmer TransFx External Fixation Devices are intended to be used for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
Device Story
Reprocessed Zimmer TransFx External Fixation System; modular mechanical device for orthopedic stabilization. System comprises carbon fiber/aluminum rods, clamps, and protective caps. Used by surgeons in clinical settings to construct external frames for bone fixation. Device functions via mechanical stabilization of bone segments; provides structural support for healing. Reprocessing involves cleaning, inspection, and sterilization of previously used components to restore original performance specifications. No changes to design, materials, or intended use compared to predicate devices.
Clinical Evidence
Bench and laboratory testing only. Testing included validation of reprocessing, sterilization validation, and functional performance testing to demonstrate safety and effectiveness.
Technological Characteristics
Modular external fixation system; components include carbon fiber rods, aluminum rods, and metallic clamps. Mechanical stabilization principle. Provided sterile or non-sterile. No software or electronic components.
Indications for Use
Indicated for patients requiring stabilization of fractures of long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular 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
- TRANSFX EXTERNAL FIXATION SYSTEM (K984357)
- TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM (K990848)
- TRANSFX MULTI PIN CLAMP IMMEDICA, INC (K991723)
- TRANSFX ADJUSTABLE PIN TO BAR CLAMP (K001084)
Submission Summary (Full Text)
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## PART B: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Amanda Babcock<br>Regulatory Affairs Specialist<br>(480) 763-5300 (o)<br>(480) 763-5310 (f)<br>ababcock@ascenths.com | SEP - 5 2006 |
| Date of preparation:<br>Name of device: | June 6, 2006<br>Trade/Proprietary Name: Reprocessed External Fixation<br>Devices<br>Common or Usual Name: External Fixation Devices, Fixation<br>Appliance, Single/Multiple Component<br>Classification Name: Single/Multiple Component Metallic Bone<br>Fixation Appliances and Accessories and Smooth or Threaded<br>Metallic Bone Fixation Fastener | |
| Predicate Device | |
|------------------|-----------------------------------------------|
| 510(k) Title | Manufacturer |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM |
| K991723 | TRANSFX MULTI PIN CLAMP IMMEDICA, INC |
| K001084 | TRANSFX ADJUSTABLE PIN TO BAR CLAMP |
The TransFx" External Fixation System is a modular system. Device description: The system design is designed to provide options in frame construction, simplicity in frame components, and ease of transition from one frame size to another. Intended use: Zimmer TransFx External Fixation Devices are intended to be
- used for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
- Indications Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb statement: lengthening, osteotomies, and periarticular fractures.
CONFIDENTIAL
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Kc61759 (pg 2 of 2)
| Technological<br>characteristics: | The design, materials, and intended use of the Reprocessed<br>External Fixation Devices are identical to the predicate devices.<br>The mechanism of action of the Reprocessed External Fixation<br>Device is identical to the predicate devices in that the same<br>standard mechanical design, materials, shapes and sizes are<br>utilized. There are no changes to the claims, intended use,<br>clinical applications, patient population, performance<br>specifications, or method of operation. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data: | These devices will be provided sterile and non-sterile depending<br>on customer preference.<br><br>Bench and laboratory testing was conducted to demonstrate<br>performance (safety and effectiveness) of Reprocessed External<br>Fixation Devices. This included the following tests:<br>Validation of reprocessing Sterilization Validation (for sterile devices) Function test(s)<br>Performance testing demonstrates that Reprocessed External<br>Fixation Devices perform as originally intended. |
| Conclusion: | Ascent Healthcare Solutions concludes that the modified<br>devices (Reprocessed External Fixation Device) are safe,<br>effective, and substantially equivalent to the predicate devices<br>as described herein. |
CONFIDENTIAL
:
Traditional 510(k)
:
10
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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling human figures or birds, arranged in a row.
### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions % Ms. Amanda Babcock Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044
SEP - 5 2006
Re: K061759
Trade/Device Name: Reprocessed Zimmer TransFxTM 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: Class II Product Code: KTT Dated: June 20, 2006 Received: June 22, 2006
Dear Ms. Babcock:
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.
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Page 2 - Ms. Amanda Babcock
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 (240) 276-0120 . 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Barbara Buettner
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Page 3 – Ms. Amanda Babcock
Reprocessed Zimmer TransFx™ External Fixation Devices found to be substantially equivalent:
| Intermediate 8mm | |
|---------------------------------------------------------|-------------|
| Name | Part Number |
| TransFx-Carbon Fiber Rod, 8mmx60mm | 4451-08-06 |
| TransFx-Carbon Fiber Rod, 8mmx80mm | 4451-08-08 |
| TransFx- Carbon Fiber Rod, 8mm x 100mm | 4451-08-10 |
| TransFx- Carbon Fiber Rod, 8mm x 120mm | 4451-08-12 |
| TransFx- Carbon Fiber Rod, 8mm x 140mm | 4451-08-14 |
| TransFx- Carbon Fiber Rod, 8mm x 160mm | 4451-08-16 |
| TransFx-Carbon Fiber Rod, 8mmx180mm | 4451-08-18 |
| TransFx-Carbon Fiber Rod, 8mm x 200mm | 4451-08-20 |
| TransFx-Carbon Fiber Rod, 8mm x 220mm | 4451-08-22 |
| TransFx-Carbon Fiber Rod, 8mm x 240mm | 4451-08-24 |
| TransFx- Carbon Fiber Rod, 8mm x 300mm | 4451-08-30 |
| TransFx- Carbon Fiber Rod, 8mm x 350mm | 4451-08-35 |
| TransFx-Protective Caps, 8mm | 4452-92-08 |
| TransFx-Protective Caps, 2.5/3.0mm | 4452-92-25 |
| TransFx-Protective Caps, 3./4.0mm | 4452-92-35 |
| TransFx-Rod to Rod Clamp 8mm to 8mm | 4452-10-08 |
| TransFx-Open Rod to Rod Transitional Clamp 4mm to 8mm | 4452-15-48 |
| TransFx-Open Rod to Rod Transitional Clamp, 8mm to 11mm | 4452-15-81 |
| TransFx-Open Rod to Rod clamp, 8mm to 8mm | 4452-15-88 |
| TransFx-Open Pin to rod Clamp, 2.5 to 4.5mm/8mm | 4452-25-28 |
| TransFx-Multi-Pin Clamp, 8mm, Single Connect | 4452-30-08 |
| TransFx-Multi-Pin Clamp, 8mm, End Connect | 4452-31-08 |
| TransFx-Multi-Pin Clamp, 8mm, Mid Connect | 4452-32-08 |
| Large 11mm | |
| Name | Part Number |
| TransFx-Carbon Fiber Rod, 11mmx100mm | 4451-01-10 |
| TransFx-Carbon Fiber Rod, 11mmx125mm | 4451-01-12 |
| TransFx-Carbon Fiber Rod, 11mmx150mm | 4451-01-15 |
| TransFx-Carbon Fiber Rod, 11mmx200mm | 4451-01-20 |
| TransFx-Carbon Fiber Rod, 11mmx250mm | 4451-01-25 |
| TransFx- Carbon Fiber Rod, 11mmx300mm | 4451-01-30 |
| TransFx-Carbon Fiber Rod, 11mmx350mm | 4451-01-35 |
| TransFx-Carbon Fiber Rod, 11mm x 400mm | 4451-01-40 |
| TransFx-Carbon Fiber Rod, 11mmx450mm | 4451-01-45 |
| TransFx-Carbon Fiber Rod, 11mmx500mm | 4451-01-50 |
| TransFx-Carbon Fiber Rod, 11mmx550mm | 4451-01-55 |
| TransFx-Carbon Fiber Rod, 11mmx600mm | 4451-01-60 |
| TransFx-Carbon Fiber Rod, 11mmx650mm | 4451-01-65 |
| TransFx-Aluminum Angled Rod, 11mm x 135mm | 4451-01-91 |
| TransFx-Aluminum Angled Rod, 11mm x 180mm | 4451-01-92 |
| TransFx-Protective Caps, 11mm | 4452-92-11 |
| TransFx-Protective Caps, 4.5/5.0mm | 4452-92-45 |
| TransFx-Rod to Rod Clamp 11mm to 11mm | 4452-10-11 |
| TransFx-Open Rod to Rod Clamp 11mm to 11mm | 4452-15-1 |
| TransFx-Open Pin to Rod Clamp, 4.0 to 6.0mm/11mm | 4452-25-5 |
| TransFx-Multi-Pin Clamp, 11 mm, Single Connect | 4452-30-1 |
| TransFx-Multi-Pin Clamp, 11 mm, End Connect | 4452-31-1 |
| TransFx-Multi-Pin Clamp, 11 mm, Mid Connect | 4452-32-1 |
| TransFx-Adjustable Clamp, 4.0 to 6.0mm/11 mm | 4452-35-5 |
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# Page 4 – Ms. Amanda Babcock
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#### 2. Indications for Use
## 510(k) Number (if known): K061759
Device Name: Ascent Healthcare Solutions Reprocessed External Fixation Devices
Indications for Use: Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
Prescription Use (Part 21 CFR 801 Subpart D)
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)
barbare buchnofformxn
Division Sign Off
(Division Sign-Of Division of General, Restorative, and Neurological Devices
**510(k) Number** K061175
Ascent Healthcare Solutions Reprocessed External Fixation Device Traditional 510(k)
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