PRECIMED HIP SCREW SYSTEM

K023851 · Precimed, Inc. · KTT · Jan 28, 2003 · Orthopedic

Device Facts

• Record ID: K023851
• Device Name: PRECIMED HIP SCREW SYSTEM
• Applicant: Precimed, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.

Device Story

Precimed Hip Screw System is a metallic bone fixation system for femoral neck and distal femoral fractures. Components include compression plates, lag screws, compression screws, bone screws, and angled blade plates. Used in clinical/surgical settings by orthopedic surgeons to provide immediate stability and temporary fixation during the natural bone healing process. The device is implanted to stabilize fractures or osteotomy sites, facilitating patient recovery through mechanical support.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Materials: 316 LVM stainless steel or Titanium alloy 6Al-4V per ASTM and ISO standards. System consists of compression plates, lag screws, compression screws, bone screws, and angled blade plates. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for patients requiring surgical treatment of femoral neck and distal femoral fractures, including displaced sub-capital, subtrochanteric, and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, and hip or distal femoral osteotomies.

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

• AMBI Hip Screw System (S &N Richards)
• HDS / DCS Dynamic Hip & Condylar Screw System (Synthes)
• Syntec-Taichung DHS / DCS Plate System (Syntec-Taichung Medical Instrument Co.)

Submission Summary (Full Text)

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JAN 2 8 2003 K023851

Summary of Safety and Effectiveness
for
**Precimed Hip Screw System**

This safety and effectiveness summary for the Previded as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

1. Submitter : Precimed, Inc. 50 Devyn Drive Chester Springs, PA 19425

Date Prepared: November 15, 2002

Contact Person : Barbara Lyons 50 Devyn Drive Chester Springs, PA 19425 Telephone: (610 ) 524-8300

2. Tradename: Precimed Hip Screw System Compression Hip Screw and Supracondylar Plate System Common Name: Classification Name: Single/ multiple component metallic bone fixation appliances and accessories ( 888.3030 )

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

- AMBI Hip Screw System ( S &N Richards ) .
- . HDS / DCS Dynamic Hip & Condylar Screw System ( Synthes )
- Syntec-Taichung DHS / DCS Plate System ( Syntec-Taichung Medical Instrument Co. ) .

#### 4. Description of the device :

The Precimed Hip Screw System is a compression fixation system used for the treatment of femoral neck and distal femoral fractures. It consists of compression plates, lag screws, compression screws, bone screws and angled blade plates.

- Materials: The devices are manufactured from 316 LVM stainless steel or Titanium alloy 6Al-4V per ASTM and ISO standards.
- The system functions to provide immediate stability and temporary fixation during Function: the natural healing process following fractures of the femoral neck or distal femur.

#### 5. Intended Use:

The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.

- 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the Precimed Hip 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2003

Ms. Barbara Lyons Precimed, Inc. 50 Devyn Drive Chester Springs, Pennsylvania 19425

Re: K023851 Trade Name: Precimed Hip Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 15, 2002 Received: November 19, 2002

Dear Ms. Lyons:

We have reviewed your Section 510(k) premarket 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) 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 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) 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,

Sincerely yours,
Mark A Milkerss

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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# 510(k) Number (if known ) :

Device Name : Precimed Compression Hip Screw System

KOD 3851 Indications For Use :

The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femur fractures.

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## Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription use > ( PER 21 CFR 801.109)

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OR

Over-the-counter use

( optional format 1-2-96 )

Mark A. Milliken

17 - Off Restorative

K02385