TWIST-OFF (TM) SCREW

K971069 · Landos, Inc. · HWC · Jul 9, 1997 · Orthopedic

Device Facts

• Record ID: K971069
• Device Name: TWIST-OFF (TM) SCREW
• Applicant: Landos, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.

Device Story

Twist-off™ Screw is a titanium alloy orthopedic implant; 2.0mm diameter; 11-14mm length; features self-tapping tip and integrated support holder. Holder separates from screw automatically when screw head contacts cortical bone. Used by surgeons for hand bone fixation, fusion, or reconstruction. Mechanical design ensures proper seating via torque-controlled separation of the holder. Benefits include simplified insertion and secure fixation in small hand bones.

Clinical Evidence

Bench testing only. Testing evaluated maximum torque at rupture for holder separation (avg 0.17Nm) and screw rupture (avg 0.37Nm). No clinical data provided.

Technological Characteristics

Material: Titanium alloy. Dimensions: 2.0mm diameter, 11-14mm length. Features: Self-tapping tip, integrated break-away support holder. Principle: Mechanical torque-based separation of holder upon contact with cortical bone. Non-powered, manual surgical instrument/implant.

Indications for Use

Indicated for fixation of fracture, joint fusion, or bone reconstruction (osteotomy) of the carpals, metacarpals, and phalanges of the 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

• Landos Twist-off™ Screw
• Howmedica Luhr Screw System
• Synthes Cortex Screw
• Osteomed M3 Screw

Submission Summary (Full Text)

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06/26/97 THU 15:10 FAX [phone] DePuy Clinical & Regulat 011
K971069

# SUMMARY OF SAFETY AND EFFECTIVENESS

**MANUFACTURER IDENTIFICATION:**
Medinov-AMP
27 à 31 rue Lucien Langenieux
42335 Roanne FRANCE

**ESTABLISHMENT REGISTRATION NUMBER (Manufacturer):**
9681744
JUL - 9 1997

**SPONSOR IDENTIFICATION:**
Cheryl Hastings
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46580

**ESTABLISHMENT REGISTRATION NUMBER (Sponsor):**
1818910

**PROPRIETARY NAME:**
Twist-off™ Screw

**PRODUCT CLASSIFICATION CODE:**
87HWC

**PROPOSED REGULATORY CLASS:**
Class II

**DESCRIPTION:**
The Twist-off™ Screw is made of titanium alloy and consists of a screw integrated with a support which separates from the screw when the head meets cortical bone. It is 2.0mm in diameter and 11 to 14mm in length and has a self-tapping tip.

**INDICATIONS AND INTENDED USE:**
This screw is to be implanted for the fixation of fracture, fusion of a joint or bone reconstruction of the carpals, metacarpals and phalanges of the hand.

**PREDICATE DEVICES:**
The predicate devices for this screw are the Landos Twist-off™ Screw, the Howmedica Luhr Screw System, the Synthes Cortex Screw and the Osteomed M3 Screw.

**TESTING:**
Testing of the Twist-off™ Screw was performed for the file K962233. The maximum torque at rupture for the separation of the holder and the screw averages 0.17Nm and the maximum torque for rupture of the Twist-off™ Screw averages 0.37Nm.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL - 9 1997

Ms. Cheryl Hastings
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

Re: K971069
Twist-off™ Screw
Regulatory Class: II
Product Code: HWC
Dated: May 30, 1997
Received: June 2, 1997

Dear Ms. Hastings:

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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1. The package insert must prominently state that the device is intended for the specific use(s) described in the enclosure only; and

2. You may not label or in any way promote this device for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this

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Page 2 - Cheryl Hastings

device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, "WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.

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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Page 3 - Cheryl Hastings

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 at [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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Page 1 of 1

510(k) Number (if known): K971069

Device Name: Twist-off Screw

Indications for Use:

Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the 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)

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