(79 days)
Not Found
Not Found
No
The summary describes a mechanical plate for surgical repair and makes no mention of AI or ML.
No
The device is a mechanical augmentation for rotator cuff repair, not a therapeutic device that directly treats or cures a condition. It provides structural support.
No
The device description indicates it is a pre-bent plate used for augmentation in rotator cuff repair, fitting the description of a surgical implant rather than a device used to diagnose a medical condition.
No
The device description clearly states it is a physical plate made of titanium, which 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, tissue) to provide information about a person's health. They are used outside of the body.
- Synthes Button Plate Function: The description clearly states that the Synthes Button Plate is a surgical implant intended for the augmentation of rotator cuff repair. It is a physical device used within the body during surgery.
The intended use and device description are consistent with a surgical implant, not a diagnostic test performed on bodily fluids or tissues.
N/A
Intended Use / Indications for Use
Synthes Button Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
MBI, KGS
Device Description
Synthes Button Plate is a pre-bent plate consisting of seven holes for passing up to #5 sutures. The plate is 0.7 mm thick, 10 mm in width, and is 17 mm in length. The Button Plate is manufactured from titanium and is MRI safe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Arthrex's Bio-Button
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.
Not Found
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).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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/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. A small circled "R" trademark symbol is located to the right of the word.
: MAR 1 5 2000
.
Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The characters are 'K994364', with the 'K' being a capital letter followed by a series of numbers. The handwriting is somewhat stylized, with some characters connected and others distinct.
:
| Attachment VI | Summary of Safety and Effectiveness Information
[510(k) Summary] |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Sheri L. Musgnung |
| DEVICE NAME: | Synthes Button Plate |
| COMMON OR USUAL
NAME | Fastener, Fixation, nondegradable, Soft Tissue |
| DEVICE
CLASSIFICATION: | Class II, 21 CFR 808.3030 |
| PREDICATE DEVICE: | Arthrex's Bio-Button |
| DESCRIPTION: | Synthes Button Plate is a pre-bent plate consisting of seven holes
for passing up to #5 sutures. The plate is 0.7 mm thick, 10 mm
in width, and is 17 mm in length. The Button Plate is
manufactured from titanium and is MRI safe. |
| INTENDED USE: | Synthes Button Plate is intended for augmentation of
transosseous rotator cuff repair, especially in massive tears and
reruptures in proximity to osteopenic bone |
CONFIDENTIAL
000049
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mar 1 5 2000
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K994364 Trade Name: Synthes Button Plate Regulatory Class: Class II Product Codes: MBI, KGS Dated: December 23, 1999 Received: December 27, 1999
Dear Ms. Musgnung:
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 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). 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, 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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. Sheri L. Musgnung
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) 594-4595. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Niel R. Ogle
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
3
| 1 | |||
|---|---|---|---|
| A Children Controller | |||
| ------------ | |||
| AAA | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
| A .- CHEVROL COLL LEVELLE .- CHE .- CHE .- CHERE A LA | |||
| 510(k) Number (if known): | K994364 |
|---|---|
| --------------------------- | --------- |
Device Name: Synthes Button Plate
Indications For Use:
Synthes Button Plate is intended for augmentation of transosseous rotator cuff repair, especially in massive tears and reruptures in proximity to osteopenic bone.
(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 _________________________________________________________________________________________________________________________________________________________
NRO fvc cmw
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K994364 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL