(81 days)
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Not Found
No
The device description focuses on mechanical components and surgical procedures, with no mention of AI or ML terms, image processing, or data analysis.
No
The device is a surgical implant designed to stabilize fractures, which is a structural and mechanical function, not a therapeutic one that involves treating disease or restoring health through non-structural means.
No
The device is described as a plate for fracture fixation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical plate made of material, intended to be implanted as part of a surgical system. It is a hardware component.
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, or tissue) to provide information about a person's health.
- Device description: The Synthes Trochanter Stabilization Plate is a surgical implant used to stabilize bone fractures in the femur. It is a physical device that is surgically implanted into the body.
- Intended Use: The intended use is to treat bone fractures, not to analyze biological specimens.
The provided information clearly describes a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS) plating system.
Synthes Trochanter Stabilization Plate (TSP) for DHS® is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw System (DHS®).
Product codes
LXT
Device Description
The Synthes Trochanter Stabilization Plate for DHS is a component of the Synthes DHS System, which fits over the sideplate of the DHS. The spoon-shaped area of the TSP, which is proximal to the shaft, resides along the greater trochanter. Screw holes of the TSP shaft line up with the screw holes of the DHS plate to accept the 4.5 mm cortex screws used for fixation to the femoral shaft. Two screw slots accommodate the DHS lag screw and the anti-rotational screw located proximal to it. Synthes Trochanter Stabilization Plates are provided both pre-sterilized by gamma radiation and nonsterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
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
Summary of Safety and Effectiveness Information: 14.
510(k) SUMMARY
| Submitter | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Bonnie Smith
(610) 647-9700 |
| Name of the Device | Synthes (USA)
Trochanter Stabilization Plate for DHS® |
| Common or Usual
Name | Single/multiple component metallic bone fixation appliance |
| Predicate Device | Synthes (USA)
Dynamic Hip Screw (DHS®) plating system |
| Device Description | The Synthes Trochanter Stabilization Plate for DHS is a component of the
Synthes DHS System, which fits over the sideplate of the DHS. The
spoon-shaped area of the TSP, which is proximal to the shaft, resides
along the greater trochanter. Screw holes of the TSP shaft line up with the
screw holes of the DHS plate to accept the 4.5 mm cortex screws used for
fixation to the femoral shaft. Two screw slots accommodate the DHS lag
screw and the anti-rotational screw located proximal to it. Synthes
Trochanter Stabilization Plates are provided both pre-sterilized by gamma
radiation and nonsterile. |
| Intended Use | The Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to
treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric
and basilar neck fractures when used in conjunction with the Synthes
Dynamic Hip Screw (DHS) plating system. |
000010
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines above them.
Public Health Service
JUN 1 6 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie J. Smith, RAC Senior Regulatory Affairs Associate SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re: K000972
Trade Name: Synthes Trochanter Stabilization Plate for DHS® Regulatory Class: II Product Code: LXT Dated: March 24, 2000 Received: March 27, 2000
Dear Ms. Smith:
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 stared in the encreary to tical Device Amendments, or to devices that have been reclassified in encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, oond 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 (Frenancer Ipprovide), in the Code of Federal Regulations, 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 regulations.
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.
2
Page 2 - Ms. Bonnie J. Smith, RAC
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dune R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2. Indications for Use
Premarket Notification [510(k)]
INTENDED USE STATEMENT
510(k) Number (if known):
Device Name:
Indications
Synthes (USA)Trochanter Stabilization Plate for DHS®
Synthes Trochanter Stabilization Plate (TSP) for DHS® is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw System (DHS®).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | 11 | |
|---|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use_
Duane R. Lochner
Premarket Notification 510(k): Synthes (USA)Trochanter Stabilization Plate for DHS® CONFIDENTIAL
(Division Sign-Off) Division of General Restorative Devises O O C 510(k) Number 600