PRECIMED CANNULATED SCREW SYSTEM

K050754 · Precimed, Inc. · HWC · May 18, 2005 · Orthopedic

Device Facts

• Record ID: K050754
• Device Name: PRECIMED CANNULATED SCREW SYSTEM
• Applicant: Precimed, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: May 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.

Device Story

Precimed Cannulated Screw System consists of metallic screws in varying diameters and lengths; used for fixation of bone fractures and bone reconstructions. Device provides immediate stability and temporary fixation during natural bone healing process. Used in clinical settings by surgeons; implanted to stabilize fractures of tarsals/metatarsals or during osteotomies/arthrodeses. Benefits patient by maintaining bone alignment during healing.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Manufactured from 316 LVM stainless steel per ASTM and ISO standards. Cannulated screw design for bone fixation. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring fixation of bone fractures, specifically tarsal and metatarsal fractures, and for patients undergoing metatarsal or phalangeal osteotomies and arthrodeses.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Cannulated Screw System (S &N Richards)
• Cannulated Screw System (Synthes)

Submission Summary (Full Text)

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MAY 18 2005 K 050754

### Summary of Safety and Effectiveness For the Precimed Cannulated Screw System

This safety and effectiveness summary for the Precimed Cannulated Screw System is provided as required per Section 513(i)(1) of the Food, Drug and Cosmetic Act.

- Submitter: 1. Precimed, Inc. 102 Pickering Way, Suite 508
Exton, PA 19341

Contact Person: Barbara Lyons 102 Pickering Way, Suite 508 Exton, PA 19341

March 14, 2005 Date Prepared:

| 2. Tradename: | Precimed Cannulated Screw System |
|----------------------|-----------------------------------------------------------------|
| Common Name: | Cannulated Screw System |
| Classification Name: | Smooth or threaded metallic bone fixation fastener ( 888.3040 ) |

## 3. Predicate or legally marketed devices which are substantially equivalent:

- Cannulated Screw System ( S &N Richards ) .
- Cannulated Screw System ( Synthes ) .

#### 4. Description of the device :

The Precimed Cannulated Screw System is a Cannulated Screw System used for the fixation of bone fractures and for bone reconstructions. It consists of multiple sizes of cannulated screws in varying diameters and lengths.

Materials: The devices are manufactured from 316 LVM stainless steel per ASTM and ISO standards.

Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures.

#### 5. Intended Use:

The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.

- 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the Precimed Cannulated Screw System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle. The eagle is represented by four curved lines, suggesting its wings and body. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2005

Ms. Barbara Lyons Precimed Incorporated 102 Pickering Way, Suite 508 Exton, Pennsylvania 19341

Re: K050754

Trade/Device Name: Precimed Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 14, 2005 Received: March 23, 2005

Dear Ms. Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave ro rowed your 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 r ou mayy are se revisions 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 your de 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 or unf I 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 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.

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Page 2 – Ms. Barbara Lyons

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow you to begin maing of substantial equivalence of your device to a legally premation fouried.com "re 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 If you desire specific advice 10. Jour at [phone] . Also, please note the regulation entitled, Connact and office of Company to premarket notification" (21CFR Part 807.97). You may obtain Misoraliums by reference to premiento willities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

A. Hipt. Rlwdw

2 Miriam C. Provost, Ph.D. Acting 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

510(k) Number (if known):

Device Name: Precimed Cannulated Screw System

Indications for Use:

The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division

Division of General Restorative, and Neurological Devices

510(k) Number K050754