SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE

K031573 · Synthes (Usa) · KTT · Jun 6, 2003 · Orthopedic

Device Facts

• Record ID: K031573
• Device Name: SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jun 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 3.5 Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

Device Story

Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate is a metallic bone fixation device. It consists of curved and straight plates contourable in three planes with a smooth, rounded profile. Plate holes are slightly oval, allowing 30 degrees of angulation in all directions. The device accepts 3.5 mm Cortex Screws and 3.5 mm Pelvic Screws. Used by surgeons in clinical settings for orthopedic reconstruction and fracture fixation. The device provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel bone fixation plate; 3.5 mm system; contourable in three planes; oval holes allowing 30-degree angulation; compatible with 3.5 mm Cortex and Pelvic screws.

Indications for Use

Indicated for patients requiring pelvic and acetabular reconstructive surgery or fracture fixation of the distal humerus, clavicle, and scapula.

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 3.5 mm LCP Reconstruction Plate

Submission Summary (Full Text)

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03/573

## 3.0 510(k) Summary

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bonnie Smith |
| Device Name: | Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate |
| Classification: | Class II, § 888.3030 - Single/multiple component metallic bone<br>fixation appliances and accessories |
| Predicate Device: | Synthes 3.5 mm LCP Reconstruction Plate |
| Device Description: | Synthes 3.5 mm Low Profile Pelvic Reconstruction Plates consist of<br>curved plates and straight plates that are contourable in three planes.<br>The plates have a smooth, rounded profile. Plate holes are slightly oval,<br>allowing 30 degrees of angulation in all directions. The 3.5 mm Low<br>Profile Reconstruction Plate accepts Synthes 3.5 mm Cortex Screws and<br>Synthes 3.5 mm Pelvic Screws. |
| Intended Use: | Synthes 3.5 Low Profile Pelvic Reconstruction Plate is intended for<br>pelvic and acetabular reconstructive surgery and fracture fixation of the<br>distal humerus, clavicle, and scapula. |
| Materials: | Stainless steel |

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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2003

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301

Re: K031573

Trade/Device Name: Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, HRS Dated: May 14, 2003 Received: May 20, 2003

Dear Ms. Smith:

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

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## Page 2 - Ms. Bonnie J. Smith

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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 Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name:

Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate

INDICATIONS:

Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

Miriam C. Provost

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

510(k) Number K031573

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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