(68 days)
Synthes Sternal Fixation Systems
Not Found
No
The summary describes a mechanical sternal fixation system with no mention of software, algorithms, or any technology related to AI/ML.
Yes
The device is intended for the closure/repair of the sternum to stabilize it and promote fusion, which aligns with the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The device description states its use is for "closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion," which describes a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a "Synthes Titanium Locking Plates" which are physical hardware components used for sternal fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "closure/repair of the sternum following sternotomy or fracture of the stemum to stabilize the sternum and promote fusion." This describes a surgical implant used directly on the patient's body for structural support and healing.
- Device Description: The description details titanium plates and screws, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the Synthes Sternal Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
CONTRAINDICATIONS
The Synthes Titanium 2.4mm Universal Locking Plates are contra-indicated for use in acute cardiac patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Synthes Titanium Locking Plates feature compression screw holes which accept existing 2.4 and 3.0mm locking screws, have notched sides and undersides. The plates are available in lengths of 96 and 160mm with 12 and 20 holes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
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.
Synthes Sternal Fixation Systems
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
§ 888.3030 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/5 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 registered trademark symbol is located to the right of the word.
3.0
K052683 (pg 1 of 1
DEC 5 2005
| 510(k) Summary | DEC 5 2005
Page 1 of 1 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
(610) 719-5000 |
| Device Name: | Synthes Sternal Fixation System |
| Classification: | 21 CFR 888.3030: Plate, fixation, bone, non-spinal |
| Predicate Devices: | Synthes Sternal Fixation Systems |
| Device Description: | The Synthes Titanium Locking Plates feature compression screw
holes which accept existing 2.4 and 3.0mm locking screws, have
notched sides and undersides. The plates are available in lengths
of 96 and 160mm with 12 and 20 holes. |
| Intended Use: | The Synthes Sternal Fixation System is intended for use in primary
or secondary closure/repair of the sternum following sternotomy o
fracture of the sternum to stabilize the sternum and promote fusion |
| | CONTRAINDICATIONS
The Synthes Titanium 2.4mm Universal Locking Plates are contra-
indicated for use in acute cardiac patients. |
| 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 curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 5 2005
Lisa Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K052683
Trade/Device Name: Synthes Sternal Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II
Product Code: HRS Dated: November 2, 2005 Received: November 9, 2005
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 nteredments, 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 approvisions of the Act. The general controls provisions of the Act include requirements for annual provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices is classified (see above) into either class II (Special Controls) or class III (PMA), they 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 devices comply 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 Boyle
This letter will allow you to begin marketing your devices as described in your Section 510(k) This letter will and would began mains of substantial equivalence of your devices to a legally promation notificate device results in a classification for your device and thus, permits your devices to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dome office of Compliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Courter of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational 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,
Mark N. Melkerson b Acting Director Division of General, Restorative and Neurological 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 design inside. There is a line underneath the word "SYNTHES". The logo and the word are the main focus of the image.
K052683
of Page 1
·
Indications for Use
510(k) Number (if known):
KOSZ683
Device Name:
2.0
Synthes (USA) Sternal Fixation System
Indications for Use:
The Synthes Sternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the stemum to stabilize the sternum and promote fusion.
CONTRAINDICATIONS
The Synthes Titanium 2.4mm Universal Locking Plates are contraindicated for use in acute cardiac patients.
X Prescription Use (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 | K052683 |
|---|---|
| --------------- | --------- |