(71 days)
Not Found
Not Found
No
The summary describes a mechanical external fixator and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "Elbow Hinge Fixator" intended for "supplementary treatment of complex, unstable elbow injuries" and for "guided joint bridging". These applications indicate a therapeutic purpose by providing support and stability to an injured joint to aid in healing and functional recovery.
No
Explanation: The device is an external fixator intended for supplementary treatment and stabilization of elbow injuries, not for diagnosing them. It is a therapeutic device.
No
The device description clearly states it consists of physical components (rods made of carbon fiber reinforced PEEK and a stainless steel joint), indicating it is a hardware medical device, not software-only.
Based on the provided information, the Synthes Elbow Hinge Fixator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of the Synthes Elbow Hinge Fixator clearly indicate it is a surgical implant/external fixator used to stabilize and support the elbow joint during healing. It is applied externally to the body and does not involve the analysis of biological specimens.
Therefore, this device falls under the category of a medical device used for surgical and orthopedic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability.
The indications for guided joint bridging with external fixators are:
-Delayed treatment of dislocated and stiff elbows
-Chronic, persistent joint instability
-Acute joint instability after complex ligament injuries
-Unstable elbow fractures
-Additional stabilization of post-operative unstable internal fixation
Product codes
LXT
Device Description
The Synthes Elbow Hinge Fixator consists of two rods, which are interconnected through a riveted joint, allowing a hinge-like movement. The rods are made of carbon fiber reinforced PEEK, and the joint is made of stainless steel. The overall length of the device is 180mm and the achievable range of motion averages 270 degrees.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow
Indicated Patient Age Range
Adults, children and small stature adults
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker-Dynamic Joint Distractor II
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line below the word. The registered trademark symbol is to the right of the word.
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| MAR 07 2007 | ||
| Contact: | Jennifer Perks | |
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| 610-719-6941 | ||
| Device Name: | Synthes (USA) Elbow Hinge Fixator | |
| Classification: | The classification of the Synthes Elbow Hinge Fixator as per 21 of | |
| the Code of Federal Regulations, Section 888.3030 – | ||
| Single/Multiple Component metallic bone fixation appliances and | ||
| accessories | ||
| Predicate Device: | Stryker-Dynamic Joint Distractor II | |
| Device Description: | The Synthes Elbow Hinge Fixator consists of two rods, which are | |
| interconnected through a riveted joint, allowing a hinge-like | ||
| movement. The rods are made of carbon fiber reinforced PEEK, | ||
| and the joint is made of stainless steel. The overall length of the | ||
| device is 180mm and the achievable range of motion averages 270 | ||
| degrees. | ||
| Intended Use: | The Synthes Elbow Hinge Fixator is intended for supplementary | |
| treatment of complex, unstable elbow injuries when early | ||
| functional stress must be limited due to persistent ligament | ||
| instability. | ||
| The indications for guided joint bridging with external fixators are: | ||
| -Delayed treatment of dislocated and stiff elbows | ||
| -Chronic, persistent joint instability | ||
| -Acute joint instability after complex ligament injuries | ||
| -Unstable elbow fractures | ||
| -Additional stabilization of post-operative unstable internal fixation | ||
| The Elbow Hinge Fixator is compatible with the components of the | ||
| Synthes Large External Fixator for adults, and with the components | ||
| of the Synthes Medium External Fixator for children and small | ||
| stature adults. | ||
| Substantial | ||
| Equivalence: | Documentation is provided which demonstrates the Synthes Elbow | |
| Hinge Fixator to be substantially equivalent to other legally | ||
| marketed devices. |
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1
Public Health Service
Image /page/1/Picture/2 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 symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Jennifer Perks Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380
MAR 0 7 2007
Re: K063832 Trade/Device Name: Elbow Hinge Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT Dated: December 22, 2006 Received: December 26, 2006
Dear Ms. Perks:
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.
2
Page 2 - Ms. Jennifer Perks
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark A. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is underneath the word "SYNTHES" and the logo. A registered trademark symbol is to the right of the word.
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) Elbow Hinge Fixator
Indications for Use:
The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability.
The indications for guided joint bridging with external fixators are:
-Delayed treatment of dislocated and stiff elbows
-Chronic, persistent joint instability
-Acute joint instability after complex ligament injuries
-Unstable elbow fractures
-Additional stabilization of post-operative unstable internal fixation
The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator for adults, and with the components of the Synthes Medium External Fixator for children and small stature adults.
X Prescription Use (Per 21 CFR 801.109)
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)
(Division Sign-Off)
Division of General Restorative.
Page of
Neurological Devices
Synthes (USA) ELBOW HINGE FIXATOR - 4 -
CONFIDENTIAL
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