(63 days)
Not Found
Not Found
No
The summary describes a mechanical device (pins) used for fracture stabilization and cable positioning, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a "Crimp Positioning Pin" used to guide cable positioning and provide a crimping point for cable tension fixation in orthopedic surgery, which is a mechanical aid rather than a device that treats, diagnoses, cures, mitigates, or prevents disease.
No
Explanation: The device description clearly states its purpose is for "augmenting fracture stabilization with plates used in long bone fixation" by guiding and crimping cables. This is a therapeutic and surgical aid, not a device used to diagnose a medical condition.
No
The device description clearly states the device is composed of implant quality stainless steel and titanium, indicating it is a physical hardware device, not software.
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 "augment[ing] fracture stabilization with plates used in long bone fixation." This is a surgical procedure performed on a patient's body.
- Device Description: The description details a physical implantable device ("Crimp Positioning Pins") made of stainless steel or titanium, designed to be used with surgical plates and cables.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm locking or 4.5mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.
Product codes
JDQ
Device Description
The proposed 5.0mm and 7.3mm Crimp Positioning Pins are designed to fit into the screw holes of existing Synthes fixation plates for the purpose of providing a guide for Cerclage cable positioning as well as a crimping point for Cerclage cable tension fixation.
The Crimp Positioning pins are available in versions composed of implant quality stainless steel and titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Cerclage Positioning Pin, Pioneer Surgical Technology Hex Button
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
K081205 4pg 1/17
JUL - 1 2008
Page _________ of ____ of ____________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)
Karl J. Nittinger
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6941 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins |
| Classification: | Class II, §888.3010 – Bone fixation cerclage. |
| Predicate Device: | Synthes Cerclage Positioning Pin
Pioneer Surgical Technology Hex Button |
| Device Description: | The proposed 5.0mm and 7.3mm Crimp Positioning Pins are
designed to fit into the screw holes of existing Synthes fixation
plates for the purpose of providing a guide for Cerclage cable
positioning as well as a crimping point for Cerclage cable tension
fixation.
The Crimp Positioning pins are available in versions composed of
implant quality stainless steel and titanium. |
| Intended Use: | The Synthes 5.0mm and 7.3mm Crimp Positioning Pins are
intended for use with multifilament cable to augment fracture
stabilization with plates used in long bone fixation when the use of
screws is contraindicated, as in the presence of intramedullary
implants.
The 5.0mm Crimp Positioning Pins are designed for use in the
5.0mm locking or 4.5mm LCP holes of Synthes plates. The 7.3mm
Crimp Positioning Pins are designed for use in the 7.3mm locking
holes of Synthes plates. |
| Substantial
Equivalence: | Information presented supports substantial equivalence. |
.
3.0
510(k) Summary
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 2008
Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Parkway West Chester, PA 19380
Re: K081205
Trade/Device Name: Synthes (USA) 5.0mm/7.3mm Crimp Positioning Pins Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: April 28, 2008 Received: April 29, 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 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 - Mr. Karl J. Nittinger
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
KOB 1205 (pg) / 1)
Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins Device Name:
Indications for Use:
The Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm locking or 4.5mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.
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
2.0