(219 days)
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No
The 510(k) summary describes a mechanical implant (sliding hip screw plate) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing.
Yes
The device is intended to treat fractures, which is a therapeutic purpose.
No
The device is described as a surgical implant (sliding hip screw plate device) used to treat fractures, not to diagnose them.
No
The device description explicitly states it is a "sliding hip screw plate device" manufactured from a "Titanium Alloy," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Synthes Ti. LC-DHS is a "sliding hip screw plate device" intended to treat bone fractures. This is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended use is to treat fractures, which is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the Synthes Ti. LC-DHS is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes Ti. LC-DHS is a sliding hip screw plate device, intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Synthes Ti. LC-DHS is a sliding hip screw plate device, intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. The device is manufactured from a Titanium Allov.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on mechanical test results, the Ti. LC-DHS design has been found to be substantially equivalent to the DHS design.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized image of a person's head inside of a circle. To the right of the word is a small circle with an R inside, indicating that the word is a registered trademark.
Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary]
Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647-9700 Contact: Angela J. Silvestri August 1, 1995
Synthes Titanium Limited Contact-Dynamic Hip Screw Implant (Ti. LC-DHS) is compared to Synthes Limited Contact Dynamic Hip Screw (LC-DHS) Implant and Synthes Dynamic Hip Screw (DHS) Implant.
Synthes Ti. LC-DHS is a sliding hip screw plate device, intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. The device is manufactured from a Titanium Allov.
Synthes DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. The device is manufactured from stainless steel.
Synthes will provide the Ti. LC-DHS sterile or non-sterile. Sterile devices will be gamma radiated. Of course, non-sterile devices must be sterilized prior to use, Recommended Sterilization parameters are:
| Method | Cycle | Temperature | Time |
|---|---|---|---|
| Steam | Pre-vacuum | 132° C - 135° C | 6 min. |
| Steam | Gravity | ||
| Displacement | 132° C - 135° C | 15 min. |
Based on mechanical test results, the Ti. LC-DHS design has been found to be substantially equivalent to the DHS design.
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