(75 days)
Not Found
No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for medical conditions such as fractures, joint fusion, and limb lengthening, which aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
Explanation: The device is an external fixation system used for treating fractures and performing procedures like limb lengthening and osteotomies. It is a therapeutic device that aids in the healing and stabilization of bones, rather than diagnosing conditions.
No
The device description explicitly states it is a "modular system" and mentions "frame components," indicating it is a physical hardware device used for external fixation. The performance studies also focus on bench and laboratory testing of the physical device.
Based on the provided information, the Zimmer TransFx External Fixation Devices are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for treating fractures, joint fusion, limb lengthening, osteotomies, and periarticular fractures. These are all procedures performed directly on the patient's body for therapeutic purposes.
- Device Description: The description details a modular system for constructing external fixation frames, which are physical devices applied externally to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the human body to diagnose or monitor conditions. The Zimmer TransFx External Fixation Devices are therapeutic devices used to stabilize and support bones and joints.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed External Fixation Devices. This included the following tests: Validation of reprocessing Sterilization Validation (for sterile devices) Function test(s) Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K984357, K990848, K991723, K001084
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
PART B: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Amanda Babcock
Regulatory Affairs Specialist
(480) 763-5300 (o)
(480) 763-5310 (f)
ababcock@ascenths.com | SEP - 5 2006 |
| Date of preparation:
Name of device: | June 6, 2006
Trade/Proprietary Name: Reprocessed External Fixation
Devices
Common or Usual Name: External Fixation Devices, Fixation
Appliance, Single/Multiple Component
Classification Name: Single/Multiple Component Metallic Bone
Fixation Appliances and Accessories and Smooth or Threaded
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
1
Kc61759 (pg 2 of 2)
| Technological
characteristics: | The design, materials, and intended use of the Reprocessed
External Fixation Devices are identical to the predicate devices.
The mechanism of action of the Reprocessed External Fixation
Device is identical to the predicate devices in that the same
standard mechanical design, materials, shapes and sizes are
utilized. There are no changes to the claims, intended use,
clinical applications, patient population, performance
specifications, or method of operation. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data: | These devices will be provided sterile and non-sterile depending
on customer preference.
Bench and laboratory testing was conducted to demonstrate
performance (safety and effectiveness) of Reprocessed External
Fixation Devices. This included the following tests:
Validation of reprocessing Sterilization Validation (for sterile devices) Function test(s)
Performance testing demonstrates that Reprocessed External
Fixation Devices perform as originally intended. |
| Conclusion: | Ascent Healthcare Solutions concludes that the modified
devices (Reprocessed External Fixation Device) are safe,
effective, and substantially equivalent to the predicate devices
as described herein. |
CONFIDENTIAL
:
Traditional 510(k)
:
10
:
2
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
.
6
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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