SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES

K083573 · Synthes (Usa) · HRS · Mar 4, 2009 · Orthopedic

Device Facts

• Record ID: K083573
• Device Name: SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 3.5mm Locking Attachment Plate is intended for use with Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures and fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone.

Device Story

Synthes 3.5mm Locking Attachment Plates are low-profile, pre-contoured metallic plates designed for surgical use by orthopedic surgeons. The plates function as an augmentation system to be used in conjunction with existing Synthes LCP (Locking Compression Plate) systems. By providing additional fixation points, the plates assist in stabilizing complex fractures, such as periprosthetic fractures or those complicated by the presence of intramedullary implants. They are particularly indicated for use in osteopenic bone where standard fixation may be insufficient. The device is implanted during orthopedic surgery to provide mechanical support to the bone, facilitating healing and structural integrity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Low-profile, pre-contoured bone fixation plates. Materials: stainless steel and titanium. Designed for use with Synthes LCP (Locking Compression Plate) systems. Mechanical fixation device.

Indications for Use

Indicated for patients requiring fracture stabilization in the femur, tibia, or humerus, specifically for periprosthetic fractures or fractures involving intramedullary implants, particularly in cases of osteopenic bone.

Regulatory Classification

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.

Predicate Devices

• Synthes 1.7mm Cerclage Cable with Crimp
• Synthes Universal Locking Trochanter Stabilization Plate

Submission Summary (Full Text)

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K083573

## 3.0 510(k) Summary

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| Sponsor: | Synthes (USA)<br>Karl J. Nittinger<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] | MAR - 4 2009 |
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| Device Name: | Synthes (USA) 3.5mm Locking Attachment Plates | |
| Classification: | Class II, §888.3030 - Single / multiple component metallic bone<br>fixation appliance and accessories. | |
| Predicate Device: | Synthes 1.7mm Cerclage Cable with Crimp<br>Synthes Universal Locking Trochanter Stabilization Plate | |
| Device Description: | The Synthes 3.5mm Locking Attachment Plates are low-profile,<br>pre-contoured plates which are intended to be used with existing<br>Synthes LCP plates to stabilize fractures. The plates are available in<br>stainless steel and titanium. | |
| Intended Use: | Synthes 3.5mm Locking Attachment Plate is intended for use with<br>Synthes LCP plates to augment the stabilization of fractures,<br>including periprosthetic fractures and fractures in the presence of<br>intramedullary implants, in the femur, tibia and humerus,<br>particularly in osteopenic bone. | |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR - 4 2009

Synthes (USA) % Mr. Karl J. Nittinger Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K083573

Trade/Device Name: Synthes (USA) 3.5mm Locking Attachment Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single / multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS Dated: December 1, 2008 Received: December 4, 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. Iisting 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

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## Page 2 - Mr. Karl J. Nittinger

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

f. Ain. m.D. fos

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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2.0

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Indications for Use

510(k) Number (if known):

K083573

Device Name:

Synthes (USA) 3.5mm Locking Attachment Plates

Indications for Use: .

Synthes 3.5mm Locking Attachment Plate is intended for use with Synthes LCP plates to augment the stabilization of fractures including periprosthetic fractures, and fractures in the presence of intramedullary implants in the femur, tibia and humerus, particularly in osteopenic bone.

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)

Ar. Ai, m.D. for mxm

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

510(k) Number