(71 days)
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.
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.
The provided text [K063832] is a 510(k) summary for the Synthes (USA) Elbow Hinge Fixator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include details about acceptance criteria, specific device performance studies with sample sizes, expert ground truth establishment, or any AI-related information (such as MRMC studies, standalone algorithm performance, or training set details).
Based on the provided information, I can only provide the following:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance in the manner typically found in a clinical or performance study report. Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Stryker-Dynamic Joint Distractor II.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Substantial Equivalence Determination) |
|---|---|
| Mechanical and functional characteristics are comparable to a legally marketed predicate device. | The device consists of two rods interconnected through a riveted joint, allowing hinge-like movement. Rods are carbon fiber reinforced PEEK; joint is stainless steel. Overall length 180mm, achievable range of motion averages 270 degrees. This design and function are deemed substantially equivalent to the predicate. |
| Intended use and indications are equivalent to a legally marketed predicate device. | Intended for supplementary treatment of complex, unstable elbow injuries where early functional stress must be limited. Indications include delayed treatment of dislocated/stiff elbows, chronic/acute joint instability, unstable elbow fractures, and additional stabilization of post-operative unstable internal fixation. These indications are deemed substantially equivalent to the predicate. |
| Compatibility with existing external fixator components. | Compatible with Synthes Large External Fixator components for adults and Synthes Medium External Fixator components for children and small stature adults. This compatibility is a functional aspect of the device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document does not describe a test set or data provenance for a performance study. The 510(k) process for this device relies on demonstrating substantial equivalence, which often involves engineering testing, material characterization, and comparison to the predicate device's specifications rather than a clinical trial with a "test set" as might be used for AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the document does not detail a study involving expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document does not detail a study involving adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical orthopedic fixator, not an AI-based diagnostic or assistive software, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study of an algorithm was not done. This device is a mechanical orthopedic fixator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as the document does not describe a study involving ground truth. The basis for clearance is substantial equivalence to a predicate device, supported by engineering considerations and functional comparisons.
8. The sample size for the training set
This information is not provided. This device is a mechanical medical device, not an AI system, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not provided. As explained above, there is no "training set" for this type of device.
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| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-5000MAR 07 2007 | |
| Contact: | Jennifer PerksSynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380610-719-6941 | |
| Device Name: | Synthes (USA) Elbow Hinge Fixator | |
| Classification: | The classification of the Synthes Elbow Hinge Fixator as per 21 ofthe Code of Federal Regulations, Section 888.3030 –Single/Multiple Component metallic bone fixation appliances andaccessories | |
| Predicate Device: | Stryker-Dynamic Joint Distractor II | |
| Device Description: | The Synthes Elbow Hinge Fixator consists of two rods, which areinterconnected through a riveted joint, allowing a hinge-likemovement. The rods are made of carbon fiber reinforced PEEK,and the joint is made of stainless steel. The overall length of thedevice is 180mm and the achievable range of motion averages 270degrees. | |
| Intended Use: | The Synthes Elbow Hinge Fixator is intended for supplementarytreatment of complex, unstable elbow injuries when earlyfunctional stress must be limited due to persistent ligamentinstability. | |
| 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 theSynthes Large External Fixator for adults, and with the componentsof the Synthes Medium External Fixator for children and smallstature adults. | ||
| SubstantialEquivalence: | Documentation is provided which demonstrates the Synthes ElbowHinge Fixator to be substantially equivalent to other legallymarketed devices. |
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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.
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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
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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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2.0
§ 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.