(59 days)
Synthes LC-DHS
Not Found
No
The summary describes a mechanical plate and screw system for fracture fixation and contains no mention of AI or ML technology.
Yes
The device is described as a plate and screw system "to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures," which clearly indicates a therapeutic intent to manage a medical condition.
No
The "Intended Use / Indications for Use" states that the device is "to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a "plate and screw system," which are physical hardware components used in orthopedic surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures." This describes a surgical implant used to fix bone fractures within the body.
- Device Description: The device is described as a "plate and screw system" designed to be implanted to stabilize bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The provided description does not mention any such function.
Therefore, the Synthes DHS Helix System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synthes DHS Helix System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Product codes
JDO
Device Description
Synthes DHS Helix System is a plate and screw system. The DHS plate is a straight with an angled barrel portion that accepts a helix screw. The barrel angles are available in various degrees and the plates are available in multiple lengths. The plate accepts the DHS Helix Screw (lengths ranging from 75 mm to 130 mm) and 4.5 mm cortex screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intertrochanteric, subtrochanteric and basilar neck
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)
Synthes LC-DHS
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
{
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A small circle with a dot in the center is located to the upper right of the letter "S" in "SYNTHES".
Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '981757'. The numbers are written in a simple, clear style, and the image appears to be a close-up of the sequence.
Summary of Safety and Effectiveness Information [510(K) Summary]
| SPONSOR | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Angela Silvestri |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON OR USUAL
NAME: | Bone Plate and Bone Screw |
| DEVICE
CLASSIFICATION | Class II, 21 CFR 888.3030 and 888.3040 |
| PREDICATE DEVICE: | Synthes LC-DHS |
| DESCRIPTION: | Synthes DHS Helix System is a plate and screw system. The
DHS plate is a straight with an angled barrel portion that accepts
a helix screw. The barrel angles are available in various degrees
and the plates are available in multiple lengths. The plate
accepts the DHS Helix Screw (lengths ranging from 75 mm to
130 mm) and 4.5 mm cortex screws. |
| INTENDED USE: | Synthes DHS Helix System is intended to treat stable and unstable
intertrochanteric, subtrochanteric and basilar neck fractures in
which a stable medial buttress can be reconstructed. |
| MATERIAL: | Stainless Steel |
CONFIDENTIAL
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Ms. Angela J. Silvestri ·Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K981757 Synthes (USA) DHS Helix System Regulatory Class: II Product Code: JDO Dated: May 18, 1998 Received: May 19, 1998
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements 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 requlations.
2
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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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 stylized image inside. The logo appears to be a symbol representing the company or brand. A small registration mark is present to the right of the word.
....
.
Indications for Use Statement 2.0
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | K981757 |
| Device Name: | Synthes (USA) DHS Helix System |
| Indications for use: |
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
、、
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Sign-Off
| K981757 | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
| DHS Helix System Synthes (USA) | |
|---|---|
| -------------------------------- | -- |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | CONFIDENTIAL |
|---|---|
| --------------- | -------------- |
04