3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)

K992837 · Synthes (Usa) · KTW · Oct 25, 1999 · Orthopedic

Device Facts

• Record ID: K992837
• Device Name: 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
• Applicant: Synthes (Usa)
• Product Code: KTW · Orthopedic
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.

Device Story

Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates provide stable fracture fixation and rotational control for proximal humerus and distal tibia fractures. Device features low-profile limited contact dynamic compression plate (LC-DCP) design with dynamic compression unit (DCU) screw holes. Blade portion is cannulated to accept 2.0 mm guide wire for precise placement. Available in various sizes to accommodate patient anatomy. Used by orthopedic surgeons in clinical/surgical settings to stabilize bone segments, promoting healing and restoring structural integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Implant-quality stainless steel and commercially pure titanium. Design: 3.5 mm 90° angled blade plate, cannulated for 2.0 mm guide wire, low-profile LC-DCP design with DCU screw holes. Mechanical fixation device.

Indications for Use

Indicated for patients requiring fixation of fractures and non-unions of the proximal humerus and distal tibia.

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 Small T-Plate
• Ace DePuy Symmetry Proximal Humerus Plate

Submission Summary (Full Text)

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OCT 2 5 1999

## 3.0 Summary of Safety and Effectiveness Information

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Angela Silvestri |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes 3.5 mm 90° Cannulated Limited Contact-Angled Blade Plates |
| CLASSIFICATION: | 21 CFR 888.3030 Single/multiple component metallic bone fixation<br>appliances and accessories. |
| PREDICATE DEVICE: | Synthes Small T-Plate<br>Ace DePuy Symmetry Proximal Humerus Plate |
| DEVICE DESCRIPTION: | Synthes 3.5 mm 90° Cannulated LC-ABP provides stable fracture fixation<br>and rotational control for fractures of the proximal humerus and distal tibia.<br>The plates feature a low profile limited contact dynamic compression plate<br>(LC-DCP®) design and dynamic compression unit (DCU) screw holes.<br>The blade portion of the plate is cannulated to accept a 2.0 mm guide wire.<br>The plates are available in various sizes to accommodate varying patient<br>anatomy. |
| INTENDED USE: | These plates are intended for the fixation of fractures and non-unions of the<br>proximal humerus and distal tibia. |
| MATERIAL: | Implant quality stainless steel and commercially pure titanium |

Confidential

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 1999

Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

K992837 Re: Synthes (USA) 3.5mm 90° Cannulated Limited Contact Angled Blade Plates Requlatory Class: II Product Code: KTW Dated: Auqust 20, 1999 August 23, 1999 Received:

Dear Ms. Silvestri:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಡಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Angela J. Silvestri

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Foll
Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2.0 Indications for Use Statement

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510(k) Number (if known):

Synthes (USA) 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates Device Name:

Indications/Contraindications:

Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992831

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Synthes (USA) 3.5 mm 90° Cannulated LC-ABP 510(k) Confidential