SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM

K000684 · Synthes (Usa) · KTT · Apr 28, 2000 · Orthopedic

Device Facts

• Record ID: K000684
• Device Name: SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Apr 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

Device Story

Small Fragment Dynamic Compression Locking (DCL) System consists of limited-contact profile plates (straight, reconstruction, Oblique T-, Small T- configurations) and 3.5 mm locking screws; also compatible with 2.7 mm/3.5 mm cortex and 4.0 mm cancellous screws. Plates feature combination dynamic compression/locking screw holes. Used by surgeons for internal bone fixation in fractures, osteotomies, and non-unions. Provides mechanical stabilization of bone segments to facilitate healing, particularly in osteopenic bone where traditional fixation may be less secure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of metallic bone plates and screws. Materials: stainless steel or titanium. Features: limited-contact profile plates with combination dynamic compression/locking screw holes. Dimensions: various sizes for small fragment fixation. Sterilization: not specified. Energy source: none (mechanical device).

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 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates
• Synthes Small Reconstruction Plates
• Synthes 2.7 mm Reconstruction Plates
• Synthes Small T-Plate

Submission Summary (Full Text)

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K000684

## Summary of Safety and Effectiveness Information: 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | [phone] |
| CONTACT: | Angela Silvestri |
| DEVICE NAME: | Synthes Small Fragment Dynamic Compression Locking (DCL)<br>System |
| DEVICE CLASSIFICATION: | 21 CFR 888.3030 Single/multiple component metallic bone fixation<br>appliances and accessories and 888.3040 Smooth/threaded metallic<br>bone fixation fastener. |
| PREDICATE DEVICE: | Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates<br>Synthes Small Reconstruction Plates, Synthes 2.7 mm Reconstruction<br>Plates, and Synthes Small T-Plate. |
| DESCRIPTION OF DEVICE: | The Small Fragment DCL system consists of limited-contact profile<br>plates in straight, reconstruction, Oblique T- and Small T- plates of<br>various sizes and 3.5 mm locking screws. The plates in this system<br>also accept 2.7 mm and 3.5 mm cortex, and 4.0 mm cancellous<br>screws. The plates feature a combination dynamic<br>compression/locking screw hole. The system is available in either<br>stainless steel or titanium. |
| INDICATIONS: | Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula,<br>olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in<br>osteopenic bone. |

Sm. Frag. Dynamic Compression Locking System 510(k) Synthes (USA)

CONFIDENTIAL

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2000

Ms. Angela J. Silvestri Manager, Regulatory Affairs SYNTHES (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301-1222

Re: K000684

Trade Name: Small Fragment Dynamic Compression Locking (DCL) System Regulatory Class: II Product Code: KTT Dated: February 25, 2000 Received: February 29, 2000

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 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 (OS) 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 (GD) 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 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.

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.

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Page 2 - Ms. Angela J. Silvestri

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,

vonne R. Kirchner.

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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## Indications for Use Statement 1.0

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1000684 510(k) Number (if known):

Synthes (USA) Small Fragment Dynamic Compression Locking (DCL) System_ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for use:

Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Donna R. Lochner.

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_KOOO 684

CONFIDENTIAL

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