SYNTHES (USA) DHS HELIX SYSTEM

K981757 · Synthes (Usa) · JDO · Jul 17, 1998 · Orthopedic

Device Facts

• Record ID: K981757
• Device Name: SYNTHES (USA) DHS HELIX SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JDO · Orthopedic
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes DHS Helix System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

Device Story

Synthes DHS Helix System is an orthopedic bone plate and screw system used for fracture fixation. The system consists of a straight plate with an angled barrel portion and a helix screw. The device is implanted by a surgeon in an operating room setting to stabilize fractures. The plate accepts the DHS Helix Screw (75 mm to 130 mm lengths) and 4.5 mm cortex screws. By providing mechanical fixation, the system supports bone healing and fracture stabilization, allowing for the reconstruction of a stable medial buttress in the hip region.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Stainless steel. Components: Straight plate with angled barrel, helix screw (75-130 mm), and 4.5 mm cortex screws. Mechanical fixation system.

Indications for Use

Indicated for patients with stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures where a stable medial buttress can be reconstructed.

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 LC-DHS

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness Information [510(K) Summary]

| SPONSOR | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Angela Silvestri |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| COMMON OR USUAL<br>NAME: | Bone Plate and Bone Screw |
| DEVICE<br>CLASSIFICATION | Class II, 21 CFR 888.3030 and 888.3040 |
| PREDICATE DEVICE: | Synthes LC-DHS |
| DESCRIPTION: | Synthes DHS Helix System is a plate and screw system. The<br>DHS plate is a straight with an angled barrel portion that accepts<br>a helix screw. The barrel angles are available in various degrees<br>and the plates are available in multiple lengths. The plate<br>accepts the DHS Helix Screw (lengths ranging from 75 mm to<br>130 mm) and 4.5 mm cortex screws. |
| INTENDED USE: | Synthes DHS Helix System is intended to treat stable and unstable<br>intertrochanteric, subtrochanteric and basilar neck fractures in<br>which a stable medial buttress can be reconstructed. |
| MATERIAL: | Stainless Steel |

CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 1998

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

Re: K981757 Synthes (USA) DHS Helix System Regulatory Class: II Product Code: JDO Dated: May 18, 1998 Received: May 19, 1998

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 Requlations, 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 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 requlations.

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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,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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Indications for Use Statement 2.0

| | Page 1 of 1 |
|---------------------------|--------------------------------|
| 510(k) Number (if known): | K981757 |
| Device Name: | Synthes (USA) DHS Helix System |
| Indications for use: | |

To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.

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

Concurrence of CDRH Office of Device Evaluation (ODE)
*Sign-Off*

| | K981757 |
|---------------------------------------|---------|
| Prescription Use (Per 21 CFR 801.109) | |

OR
Over-The-Counter Use

| DHS Helix System Synthes (USA) | |
|--------------------------------|--|
|--------------------------------|--|

(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | CONFIDENTIAL |
|---------------|--------------|
|---------------|--------------|

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