(356 days)
Not Found
No
The summary describes mechanical external fixation devices and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is described as intended for the "treatment of various fracture types that require external fixation" and for "stabilization" and "fixation" of fractures, indicating a therapeutic purpose in aiding the healing or stability of injuries.
No.
The document describes external fixation devices used for treating fractures, not diagnosing them.
No
The device description explicitly states it consists of physical external fixation devices, which are hardware. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes the Synthes External Fixation Devices as being used to construct external fixation frames for treating fractures. This involves physically stabilizing bones within the body (in vivo).
The device is a surgical implant/device used for musculoskeletal support and stabilization, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.
Synthes Distal Radius Fixator is intended for the fixation of the distal radius.
Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
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
KTT
Device Description
The Synthes External Fixation Devices, MR Conditional consists of previously cleared Medium External Fixation, Distal Radius Fixator, Low-profile Wrist Fixator and Elbow Hinge Fixator devices that are used to construct an external fixation frame.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult fractures
Intended User / Care Setting
Prescription Use
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)
Synthes Medium External Fixation, Synthes Distal Radius Fixator, Synthes Low Profile Wrist Fixator, Synthes Elbow Hinge Fixator, Synthes Large External Fixation, MR Conditional
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.
0
. · MAR - 3 2010
.
Image /page/0/Picture/2 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized image inside. A horizontal line is present below the word. A registered trademark symbol is present to the right of the word.
(
3.0 510(k) Summary
Page _________________________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-5000 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jill R. Yelton
Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
Phone: (610) 719-6538
Fax: (484) 356-9682 |
| Device Name: | Synthes External Fixation Devices, MR Conditional |
| Classification: | 21 CFR Part 888.3030; Single/multiple component metallic bone fixation
appliances and accessories. |
| Predicate Devices: | Synthes Medium External Fixation
Synthes Distal Radius Fixator
Synthes Low Profile Wrist Fixator
Synthes Elbow Hinge Fixator
Synthes Large External Fixation, MR Conditional |
| Device
Description: | The Synthes External Fixation Devices, MR Conditional consists of
previously cleared Medium External Fixation, Distal Radius Fixator, Low-
profile Wrist Fixator and Elbow Hinge Fixator devices that are used to
construct an external fixation frame. |
| Intended Use: | Synthes External Fixation Devices, MR Conditional are intended for use
in the construction of an external fixation frame for treatment of various
fracture types that require external fixation. |
Information presented supports substantial equivalence.
Substantial Equivalence
.
·
ﻟﻤﺴﺘﻨﻴﻪ ﻋ
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem is a representation of a human figure with outstretched arms, symbolizing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Synthes (USA) c/o Ms. Jill R. Yelton Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAR - 3 2010
Re: K090658
Trade/Device Name: Synthes External Fixation Devices, MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance Regulatory Class: Class II Product Code: KTT Dated: December 21, 2009 Received: December 22, 2009
Dear Ms. Yelton:
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
2
Page 2 - Ms. Jill R. Yelton
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you dosite specific and AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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. There is a horizontal line underneath the word "SYNTHES" and the logo. To the right of the word "SYNTHES" is a small circle with an R inside, indicating a registered trademark.
Indications for Use
510(k) Number (if known):
2.0
KO90658
Synthes External Fixation Devices, MR Conditional Device Name:
Indications for Use: Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.
Synthes Distal Radius Fixator is intended for the fixation of the distal radius.
Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
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 System for adults (rod diameter: Øl 1 mm), and with components of the Synthes Medium External Fixator System (rod diameter: Ø8mm) for children and small stature adults.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 807 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number | K090658 |
|---|---|
| --------------- | --------- |