(59 days)
No
The description focuses on the mechanical properties and components of a surgical implant for bone fracture fixation. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the treatment of various humeral shaft fractures, indicating its direct role in managing a disease or condition.
No
The device is described as an intramedullary fixation device intended for the treatment of humeral shaft fractures, not for diagnosis.
No
The device description clearly describes a physical, implantable medical device made of titanium alloy, including nails, bolts, screws, and end caps. It is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Synthes FlexNail Function: The Synthes FlexNail is an implantable medical device used to fix bone fractures within the body. It is a physical device that provides structural support and stability to a broken bone.
The description clearly states its purpose is for the "treatment of humeral shaft fractures" and describes it as a "flexible, non-reamed, locking intramedullary fixation device." This is entirely consistent with a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Synthes FlexNail is intended for treatment of humeral shaft fractures; specifically, it is for treatment of acute humeral shaft fractures, including certain pre- and post-isthmal fractures (including, but not limited to transverse, short oblique, long oblique, butterfly, and segmental fractures, of all grades of comminution); pathologic or impending pathologic fractures; and non- and malunions of the humeral shaft.
Product codes
JDS
Device Description
Synthes FlexNail is a flexible, non-reamed, locking intramedullary fixation device that is capable of sharing normal weight-bearing loads with the fixed fractured humerus. It locks within the medullary canal at either end of the bone, bridging the fracture and maintaining alignment while the fracture heals. It is available in 7.0, 7.5 and 9 mm diameters, in lengths ranging from 180 to 300 mm (in 15 mm increments). Nail accessories include: a 3.9 mm Ti Locking Bolt for nail interlocking; a Tension Screw that mates with the tension block; and End Cap Screws. The "0 mm" extension End Cap Screw is used to plug the proximal connecting thread of the nail and prevent tissue in-growth to facilitate The "15 mm" extension End Cap Screw protects the removal. proximal thread of the nail and holds the proximal extension segment to the nail. This allows the nail to be overinserted by 15 mm, while leaving the proximal end of the nail accessible for removal. The FlexNail is manufactured from a titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humeral shaft
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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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SEP - 4 1997
ATTACHMENT VII: 510(k) Summary of Safety and Effectiveness Kg72S16 SUBMITTER Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Angela Silvestri Intramedullary fixation rod COMMON OR USUAL NAME: Class II, 21 CFR 888.3020; 888.3040 DEVICE CLASSIFICATION Synthes FlexNail (K953334) PREDICATE DEVICE: Synthes FlexNail is a flexible, non-reamed, locking intramedullary DESCRIPTION: fixation device that is capable of sharing normal weight-bearing loads with the fixed fractured humerus. It locks within the medullary canal at either end of the bone, bridging the fracture and maintaining alignment while the fracture heals. It is available in 7.0, 7.5 and 9 mm diameters, in lengths ranging from 180 to 300 mm (in 15 mm increments). Nail accessories include: a 3.9 mm Ti Locking Bolt for nail interlocking; a Tension Screw that mates with the tension block; and End Cap Screws. The "0 mm" extension End Cap Screw is used to plug the proximal connecting thread of the nail and prevent tissue in-growth to facilitate The "15 mm" extension End Cap Screw protects the removal. proximal thread of the nail and holds the proximal extension segment to the nail. This allows the nail to be overinserted by 15 mm, while leaving the proximal end of the nail accessible for removal. The FlexNail is manufactured from a titanium alloy. Synthes FlexNail is intended for treatment of humeral shaft INTENDED USE: fractures; specifically, it is for treatment of acute humeral shaft fractures, including certain pre- and post-isthmal fractures (including, but not limited to transverse, short oblique, long oblique, butterfly, and segmental fractures, of all grades of comminution); pathologic or impending pathologic fractures; and non- and malunions of the humeral shaft.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Stir - A
K972516 Re: Synthes (USA) Flexible Humeral Nail (FlexNail) System Regulatory Class: II Product Code: JDS Dated: July 3, 1997 Received: July 7, 1997
Dear Ms. Silvestri:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Angela J. Silvestri
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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972516
510(k) Number (if known):
Synthes (USA) Flexible Humeral Nail (FlexNail) System Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Synthes FlexNail is intended for treatment of humeral shaft fractures; specifically, it is for treatment of acute humeral shaft fractures, including certain pre- and post-isthmal fractures (including, but not limited to transverse, short oblique, long oblique, butterfly, and segmental fractures, of all grades of comminution); pathologic or impending pathologic fractures; and non- and malunions of the humeral shaft.
(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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
scollepe
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972516