SYNTHS ONE-THIRD TUBULAR DCL PLATE

K011335 · Synthes (Usa) · HRS · Jul 27, 2001 · Orthopedic

Device Facts

• Record ID: K011335
• Device Name: SYNTHS ONE-THIRD TUBULAR DCL PLATE
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Jul 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Dynamic Compression Locking Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.

Device Story

Synthes One-Third Tubular DCL Plate is a line extension of the existing Synthes Third Tubular Plate; modified to include threaded holes for locking screws. Device functions as part of the Synthes Small Fragment DCL System for bone fixation. Used by surgeons in clinical settings to stabilize fractures, osteotomies, or non-unions. Locking mechanism provides stability, particularly beneficial in osteopenic bone where traditional screw purchase may be compromised. Output is a mechanical fixation construct.

Clinical Evidence

Bench testing only.

Technological Characteristics

Bone fixation plate with threaded holes for locking screws. Material and sterility options are identical to the predicate device. Designed for use within the Synthes Small Fragment DCL System.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in patients with 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 Third Tubular Plate (Pre-Amendment)
• Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUL 2 7 2001

: .

011335

.

#### 3. Summary of Safety and Effectiveness Information

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 |
| Name of the Device | Synthes One-Third Tubular DCL Plate |
| Regulation & Classification | Class II, §888.3030 - Plate, Fixation, Bone<br>(HRS) |
| Predicate Device | Synthes Third Tubular Plate (Pre-Amendment)<br>Synthes Small Fragment Dynamic Compression Locking (DCL)<br>System (K000684) |
| Device Description | Synthes One-Third Tubular DCL Plate line extension is a threaded<br>version of the currently marketed Synthes Third Tubular Plate. The<br>threaded plates will accept locking screws and therefore can be<br>included as part of the Small Fragment DCL System. The new plates<br>have the same intended use as other plates in the system and there is<br>no change in safety or efficacy. |
| Intended Use | Synthes Dynamic Compression Locking Plate System is intended for<br>fixation of fractures, osteotomies, and non-unions of the clavicle,<br>scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and<br>fibula, particularly in osteopenic bone as a part of the Synthes Small<br>Fragment DCL System. |
| Technological<br>Characteristics | The Synthes One-Third Tubular Plate has the same technological<br>characteristics as the predicate device/ system identified above. Both<br>will be offered in the same materials and with the same sterility<br>options. The only difference is that these new plates will have the<br>locking threads and be offered as a part of the Synthes Small<br>Fragment DCL System. |

Abbreviated 510(k): Synthes One-Third Tubular Plate for the Small Fragment DCL System (Line Extension) CONFIDENTIAL

{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 graphic of three human profiles facing right, layered on top of each other. The profiles are black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

Public Health Service

## JUL 2 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Matthew M. Hull, RAC Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K011335

Trade Name: Synthes One-Third Tubular DCL Plate Regulation Number: 21 CFR 888.3030 Regulatory Class: II Product Code: HRS Dated: April 30, 2001 Received: May 2. 2001

Dear Mr. Hull:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou 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.

{2}------------------------------------------------

## Page 2 - Mr. Matthew M. Hull, RAC

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Bmtcheetuthor

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

{3}------------------------------------------------

#### 8. Indications for Use Statement

Page 1 of 1

510(k) Number (if known):

Device Name:

Indications/ Contraindications:

# KO11335

Synthes One-Third Tubular Plate

Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

взткишичкортскии

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

Abbreviated 510(k): Synthes One-Third Tubular1fdffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffffff nt DCL System (Line Extension) CONFIDENTIAL

000011