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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the "Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins". It establishes substantial equivalence to predicate devices and describes the intended use and device characteristics.

However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory clearance document, not a clinical or performance study report. Therefore, I cannot complete the table or answer most of the questions as the requested information is absent from the provided text.

Here is what can be inferred or stated as not present:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the document. This document is a 510(k) clearance, not a study report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, nor is this device an AI-based system. This is a medical implant, not a diagnostic or AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the document.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is a physical medical device, not an AI model.

Summary

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K081205 4pg 1/17

JUL - 1 2008

Page _________ of ____ of ____________________________________________________________________________________________________________________________________________________

Sponsor:	Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest 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 PinPioneer Surgical Technology Hex Button
Device Description:	The proposed 5.0mm and 7.3mm Crimp Positioning Pins aredesigned to fit into the screw holes of existing Synthes fixationplates for the purpose of providing a guide for Cerclage cablepositioning as well as a crimping point for Cerclage cable tensionfixation.The Crimp Positioning pins are available in versions composed ofimplant quality stainless steel and titanium.
Intended Use:	The Synthes 5.0mm and 7.3mm Crimp Positioning Pins areintended for use with multifilament cable to augment fracturestabilization with plates used in long bone fixation when the use ofscrews is contraindicated, as in the presence of intramedullaryimplants.The 5.0mm Crimp Positioning Pins are designed for use in the5.0mm locking or 4.5mm LCP holes of Synthes plates. The 7.3mmCrimp Positioning Pins are designed for use in the 7.3mm lockingholes of Synthes plates.
SubstantialEquivalence:	Information presented supports substantial equivalence.

3.0

510(k) Summary

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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.

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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

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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:

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)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

2.0

Regulation Number and Section

§ 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.