VHS PEDIATRIC HIP SCREW SYSTEM

K011603 · Walter Abendschein, M.D. · KTT · Aug 15, 2001 · Orthopedic

Device Facts

• Record ID: K011603
• Device Name: VHS PEDIATRIC HIP SCREW SYSTEM
• Applicant: Walter Abendschein, M.D.
• Product Code: KTT · Orthopedic
• Decision Date: Aug 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows : - Congenital coxa vara. 1. - Congenital dislocation of the hip 2. - 3. Subluxation or dislocation secondary to neurologic disorders, such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities. 4. Coxa plana ( Legg-Calve-Perthes disease )

Device Story

VHS™ Pediatric Hip Screw System is a metallic bone fixation device for pediatric femoral fractures. System components include adjustable plates, lag screws, compression screws, and bone screws. Device provides immediate stability and temporary fixation during natural fracture healing. Used in clinical settings by surgeons for orthopedic procedures. Output is physical stabilization of bone segments. Benefits include support for bone healing in pediatric patients with congenital or neurological-related hip/femur deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 316 LVM or 22-13-5 stainless steel per ASTM standards. Components: adjustable plates, lag screws, compression screws, bone screws. Function: mechanical compression fixation.

Indications for Use

Indicated for pediatric patients requiring fracture fixation in proximal or distal femur regions, specifically for congenital coxa vara, congenital hip dislocation, subluxation/dislocation secondary to neurologic disorders (e.g., cerebral palsy, myelomeningocele, poliomyelitis), and coxa plana (Legg-Calve-Perthes disease).

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

• Pediatric Compression Hip Screw System (Smith & Nephew Richards)
• Trauma Internal Fixation System (Smith & Nephew Inc.)
• VHS Vari-Angle Compression Hip Screw System (Biomet)
• Pediatric Osteotomy System (Howmedica)

Submission Summary (Full Text)

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K011603

Summary of Safety and Effectiveness for VHS™ Pediatric Hip Screw System

This safety and effectiveness summary for the VHS™ Pediatric Hip Screw System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

# 1. Submitter :

Walter Abendschein, M.D. 5530 Wisconsin Avenue, Suite 705 Chevy Chase, Md. 20815

# Contact Person :

Walter Abendschein, M.D. 5530 Wisconsin Avenue, Suite 705 Chevy Chase, Md. 20815 Telephone: [phone]

Date Prepared: May 22, 2001

# 2. Tradename:

VHS™ Pediatric Hip Screw System Compression Hip Screw System Common Name: Single/ multiple component metallic bone fixation appliances and accessories Classification Name: (888.3030)

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

- . Pediatric Compression Hip Screw System ( Smith & Nephew Richards )
- . Trauma Internal Fixation System ( Smith & Nephew Inc. )
- VHS Vari-Angle Compression Hip Screw System ( Biomet ) .
- Pediatric Osteotomy System ( Howmedica ) .

### 4. Description of the device :

The VHS™ Pediatric Hip Screw System is a compression fixation system used for the treatment of femoral fractures. It consists of adjustable plates, lag screws, compression screws and bone screws.

Materials: The devices are manufactured from 316 LVM or 22-13-5 stainless steel per ASTM standards.

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

#### 5. Intended Use:

The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows :

- Congenital coxa vara. 1.
- Congenital dislocation of the hip 2.
- 3. Subluxation or dislocation secondary to neurologic disorders, such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.

4. Coxa plana ( Legg-Calve-Perthes disease )

- 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the VHS™ Pediatric 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, material and intended use.

OR
/
II

51521

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AUG 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Walter Abendschein Suite 705 5530 Wisconsin Avenue Chevy Chase, Maryland 20815

Re: K011603

Trade Name: VHS™ Pediatric Hip Screw System Regulation Number: 888.3030 Regulatory Class: II Product Code: KTT Dated: May 22, 2001 Received: May 24, 2001

Dear Dr. Abendschein:

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 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 - Dr. Walter Abendschein

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific arrice for your do novelses), please contact the Office of Compliance at additionally 807.10 for m This anagliestions on the promotion and advertising of your device, [phone]. Truditionally, 101 quest 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 monthanon on your responsibility free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Amphibellonfr

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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Page 1 of 1

510(k) Number ( if known ) :

VHS™ Pediatric Hip Screw System Device Name :

Indications For Use :

The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows :

- Congenital coxa vara. 1.
- Congenital dislocation of the hip 2.
- Subluxation or dislocation secondary to neurologic disorders, 3. such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
- 4. Coxa plana ( Legg-Calve-Perthes disease )

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

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Concurrence of CDRH, Office of Device Evaluation ( ODE )

Prescription use ( PER 21 CFR 801.109)

OR

Over-the-counter use N.

( optional format 1-2-96 )

BSMukhlell HDSon CMu

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

CONFIDENTIAL

510(k) Number _