THE SPIN SNAP-OFF SCREW

K011946 · New Deal, S.A. · HWC · Aug 24, 2001 · Orthopedic

Device Facts

• Record ID: K011946
• Device Name: THE SPIN SNAP-OFF SCREW
• Applicant: New Deal, S.A.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions.

Device Story

The SPIN® SNAP-OFF Screw is a self-drilling, self-tapping bone fixation fastener. It is designed for use with standard surgical power equipment. During implantation, the screw is driven into the bone; once fully seated, the screw head is blocked, and the application of sufficient torque causes the screw to snap off, separating the head from the threaded portion. The device is used by surgeons in clinical settings for orthopedic procedures involving small bone fragments or osteotomies in the foot and hand. It provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Self-drilling and self-tapping bone screw; 2.0mm head diameter; 11-14mm length; 7-10mm distal thread length. Material: Titanium alloy. Mechanical operation via surgical power equipment with a torque-based snap-off mechanism. Class II device.

Indications for Use

Indicated for fixation of bone fractures or bone reconstruction, including small bone fragments, Weil osteotomy, mono-cortical fixation, and osteotomies/fractures in the foot and hand.

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

• SPIN SNAP-OFF screw (K991477)
• Depuy Twist-off Screw (K962233)
• Howmedica Luhr Screw system (K950595)
• Synthes 2.0mm Cortex Screw (K952272)
• Synthes 2.4mm Cortex Screw (K002271)
• Osteomed M3 Screw (K924018)
• Osteomed M3 Screw (K924138)

Submission Summary (Full Text)

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K011946

AUG 2 4 2001

# ACTIVITES & 38200

3.

# SUMMARY OF SAFETY AND EFFECTIVENESS

# SPONSOR IDENTIFICATION: A.

NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE Tél. : [phone] Fax : [phone]

# ESTABLISHMENT REGISTRATION NUMBER: B.

9615741

# C. OFFICIAL CONTACT PERSON

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 Tel. : [phone] Fax : [phone] estrin(a)vourl DAconsultant.com

### D. DATE OF PREPARATION OF THIS SUMMARY: June 20, 2001

- SPIN® SNAP-OFF SCREW E. PROPRIETARY (TRADE) NAME:
- F. COMMON NAME: Bone fixation screw,
- Self drilling and self tapping snap-off screw
- CLASSIFICATION NAME AND REFERENCE G.
- Smooth or threaded metallic bone fixation fastener (21 CFR, Section 888.3040) H. PROPOSED REGULATORY CLASS: Class II

SA au capital de 1.000.000 F - Nº Siret 412 111 510 000 19 - NAF 3318 - 412 111 510 RCS Vienne

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# DEVICE PRODUCT CODE: 1.

# 87HWC 21 CFR par. 888.3040

J. PANEL CODE:

# DESCRIPTION OF DEVICE: K.

The SPIN ® SNAP-OFF SCREW is self drilling and self tapping snap-off screw One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. In comes in lengths from 11 to 14 mm. The length varies whereas the head diameter is constant ( 2 mm) and the distal thread length is 7 mm to 10 mm.

## L. INTENDED USE:

The SPIN® SNAP-OFF Screw is intended to be implanted for fixation of bone fractures or for bone reconstructions.

# M.

INDICATIONS FOR USE:
The "new" SPIN® SNAP-QFF SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

Fixation of small bone fragments.

- . Weil osteotomy
- Mono-cortical fixation .
- Osteotomies and fractures fixation in the foot and hand

# PREDICATE DEVICE: N.

●

The "new" SPIN® SNAP-OFF SCREW is technically equivalent to the SPIN" SNAP-OFF screw currently approved (K991477). The "now" SPIN" SNAP-OFF SCREW is substantially equivalent to the Depuy Twist-off Screw (K962233), the howmedica Luhr Screw system (K950595), the 2.0mm and 2.4mm Synthes Cortex Screw (K952272and K002271) and the Osteomed M3 Screw (K924018, K924138).

## 0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The "new" SPIN® SNAP-OFF screw is technically equivalent to the device currently cleared. They have the same intended use, and the design of the active part (screw itself) has not changed. The "new" SPIN" SNAP-OFF screw, the Depuy Twist-off Screw, the howmedica Luhr Screw system, the 2.0mm and 2.4mm Synthes Cortex Screw and the Osteomed M3 Screw have the same intended use and all are indicated for fixing small fractures or osteotomics. All arc made from Titanium alloys, except the Luhr Scrow system which is provided in Cobalt-Chrome alloy, and the 2.4mm Synthes Cortex Screw which is provided in 316L. Stainless steel. The Titanium alloy used for the SPIN® SNAP-OFF SCREW is a matcrial commonly used among professionals in the orthopedic field. The "new" SPIN" SNAP-OFF screw, the Depuy Twist-off Screw, the howmedica Luhr Screw system, the 2.0mm Synthes Cortex Screw and the Ostcomed M3 Screw are 2.0mm diameter screws (range 1.2 - 3.0mm for the M3 screw system). Most have a low profile head, are self-drilling and self-tapping screws.

# P. SUMMARY OF STUDIES:

to of the torque of the "bew" SPIN" SNAP-OFF SCREW is the same as live the line the line the line the line the line the line the line the line the lines not
changed, changed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with its wings spread and head facing left. The design is simple and uses a bold, black color scheme.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2001

New Deal. S.A. C/O Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K011946

Trade Name: The Spin Snap-Off Screw Regulation Number: 888.3040 Regulatory Class: Class II Product Code: HWC Dated: June 20, 2001 Received: June 21, 2001

Dear Dr. Estrin:

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 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). You may, therefore, market the device, subject to the general controls oosisions 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 ( Feniance I Ippe any in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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

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Page 2 - Norman F. Estrin, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you dollio specific as in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (301) 594-16th of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely vours.

Mark N. Wilkerson

Celia M. Witten, Ph.D., MD 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): K01194b

SPIN® SNAP-OFF SCREW Device Name:

Indications for Use:

The "new" SPIN® SNAP-OFF SCREW is indicated for fixation of bone fractures or for bone reconstruction.

Examples include:

- Fixation of small bone fragments. ।
- Weil osteotomy ।
- Mono-cortical fixation i
- Mono ocruced and fractures fixation in the foot and hand

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

Mark N Millman

510(k) Number

00014