(87 days)
Not Found
Not Found
No
The device description focuses on mechanical components (nails, end caps, screws) for fracture fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes.
The device is intended to treat olecranon osteotomies and simple fractures, indicating it is used for the treatment or mitigation of a disease, injury or condition.
No
Explanation: The device is an Osteotomy Nailing System used for the fixation of fractures and osteotomies. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "machined metallic olecranon nails, end caps and screws," which are physical hardware components.
Based on the provided information, the Synthes Olecranon Osteotomy Nailing (OleON) System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat olecranon osteotomies and simple fractures of the olecranon. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of metallic nails, end caps, and screws designed for fixation of fractures and osteotomies. These are implantable medical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. The Synthes Olecranon Osteotomy Nailing System is used in vivo (in the living body) for surgical fixation.
N/A
Intended Use / Indications for Use
Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon.
Product codes
HSB
Device Description
Synthes Olecranon Osteotomy Nailing System consists of machined metallic olecranon nails, end caps and screws which are designed for use in fixation of fractures and osteotomies of the olecranon process of the ulna.
Synthes Olecranon Osteotomy Nailing System offers a unique alternative to current techniques for olecranon fracture and olecranon osteotomy fixation. The system allows for quick realignment of the olecranon fragment following procedures which
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
olecranon process of the ulna, olecranon
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)
Pioneer Surgical Technology SS Cables with Crimp, Synthes Kirschner Wires, Synthes 6.5mm Cancellous Screws, Acumed Small Bone Locking Rod System II, Biomet S.S.T. Small Bone Locking Forearm Nail
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 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. There is a line underneath the word "SYNTHES" and the logo. The "®" symbol is located to the right of the word.
있으며, 그래서
이
두운동
| 3.0 | 510(k) Summary | Page 1 of 1 | |
|---|---|---|---|
| Sponsor: | Synthes (USA) | ||
| Karl J. Nittinger | |||
| 1301 Goshen Parkway | |||
| West Chester, PA 19380 | |||
| (610) 719-6941 | |||
| Device Name: | Synthes Olecranon Osteotomy Nailing System | ||
| Classification: | Class II, 21 CFR 888.3020 - Intramedullary fixation rod. | ||
| Predicate Device: | Pioneer Surgical Technology SS Cables with Crimp | ||
| Synthes Kirschner Wires | |||
| Synthes 6.5mm Cancellous Screws | |||
| Acumed Small Bone Locking Rod System II | |||
| Biomet S.S.T. Small Bone Locking Forearm Nail | |||
| Device Description: | Synthes Olecranon Osteotomy Nailing System consists of | ||
| machined metallic olecranon nails, end caps and screws which are | |||
| designed for use in fixation of fractures and osteotomies of the | |||
| olecranon process of the ulna. | |||
| Synthes Olecranon Osteotomy Nailing System offers a unique | |||
| alternative to current techniques for olecranon fracture and | |||
| olecranon osteotomy fixation. The system allows for quick | |||
| realignment of the olecranon fragment following procedures which | |||
| Intended Use: | Synthes Olecranon Osteotomy Nailing (OleON) System is intended | ||
| to treat olecranon osteotomies as well as simple fractures of the | |||
| olecranon. | |||
| Substantial | |||
| Equivalence: | Information presented supports substantial equivalence. |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text is in all capital letters and is evenly spaced around the symbol.
FEB 29 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Mr. Karl J. Nittinger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K073402
Trade/Device Name: Olecranon Osteotomy Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 13, 2008 Received: February 15, 2008
Dear Mr. Nittinger:
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
2
Page 2 - Mr. Karl J. Nittinger
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millican
Mark N. Melkerson 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. A horizontal line is present below the word "SYNTHES". A registered trademark symbol is located to the right of the word.
NEEDED)
| 2.0 | Indications for Use |
|---|---|
| ----- | --------------------- |
| 510(k) Number (if known): | K073402 |
|---|---|
| Device Name: | Synthes Olecranon Osteotomy Nailing System |
| Indications for Use: |
Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranon osteotomies as well as simple fractures of the olecranon.
| Prescription Use (Per 21 CFR 801.109) | X | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|---|---|---|---|
| --------------------------------------- | --- | -------- | --------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Brown
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Ko73402