(56 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical device (washers) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a washer used to prevent screw heads from breaking through bone or projecting, distributing forces during fracture fixation. It does not directly treat or diagnose a disease or condition, which is the characteristic of a therapeutic device.
No
The device, Synthes Spherical Washers, is described as preventing a screw head from breaking through the cortex of the bone and preventing the projection of the screw head. Its function is mechanical support during fracture fixation, not diagnosis.
No
The device description clearly states it is a physical component (washers) made of Stainless Steel and Titanium, intended for use with screws in bone fracture fixation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the Synthes Spherical Washers are implantable devices used in surgical procedures for fracture fixation of bone. They are physical components used within the body, not for testing samples outside the body.
The information provided focuses on the mechanical function and application of the device in orthopedic surgery, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
Product codes
NDG, HWC
Device Description
The Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, large (long) bone and bone fragments, ankle
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 (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 13.0 mm Washer
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
A SYNTHES.
:
'K052483p.4
| NOV | 4 2005 |
|---|---|
| ----- | -------- |
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| Device Name: | Synthes Spherical Washers | |
| Classification: | 21 CFR 888.3030: Washer, bolt, nut, non-spinal, metallic (NDG) | |
| 21CFR 888.3040: Screw, Fixation, bone, non-spinal (HWC) | ||
| Predicate Devices: | Synthes 13.0 mm Washer | |
| Device Description: | The Spherical Washers are round or oval in design with a slotted | |
| center hole which allows for screw angulation up to 70 degrees. | ||
| They are used with 4.5 - 7.3 mm diameter screws and | ||
| manufactured from Stainless Steel and Titanium. | ||
| Intended Use: | The Synthes Spherical Washers are intended to prevent a screw | |
| head from breaking through the cortex of the bone by distributing | ||
| the forces/ load over a large area when used for fracture fixation of | ||
| large (long) bone and bone fragments. | ||
| In addition, the Spherical Washers are intended to prevent the | ||
| projection of the screw head, when the screw must be inserted at an | ||
| acute angle (e.g., in ankle arthrodesis). | ||
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the border of the circle.
NOV - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lisa M. Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K052483 Trade/Device Name: Synthes (USA) Spherical Washers Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: NDG, HWC Dated: October 19, 2005 Received: October 24, 2005
Dear Ms. Boyle:
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 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.
2
Page 2 - Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C. M. Malik
Mark N. Metkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
2.0
Indications for Use
510(k) Number (if known):
KC52483
Device Name:
Synthes (USA) Spherical Washers
Indications for Use:
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
Prescription Use . . - X -(Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510/k) Number_KOS 2483