MEDICON IMF-ORION SCREWS

K050478 · Medicon EG · DZE · Jun 15, 2005 · Dental

Device Facts

• Record ID: K050478
• Device Name: MEDICON IMF-ORION SCREWS
• Applicant: Medicon EG
• Product Code: DZE · Dental
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, mandible or both.

Device Story

Medicon IMF-Orion Screws are titanium alloy (Ti6Al4V) bone screws used for temporary intermaxillary fixation (IMF). Screws feature 2.0 mm shaft diameter, 4.0 mm head diameter, and lengths of 10.0–16.0 mm. The head is grooved for wire/rubber band attachment and includes a tapered inner hexagonal fitting for blade engagement. Used in healthcare facilities (hospitals, surgical centers) by surgeons/dentists to provide rapid, indirect stabilization of maxillary or mandibular fractures. Screws are applied to bone; wires or bands are then attached to the screw heads to stabilize the jaw. Benefits include reduced surgical time for fracture stabilization. Device is provided sterile.

Clinical Evidence

Clinical evidence provided via literature review, including German language publications (OP-Journal 2003, FAMI-Schraube study) and Addenbrooke's NHS study regarding the use of bicortical bone screws for temporary intermaxillary fixation. No specific clinical trial metrics (e.g., sensitivity/specificity) reported; evidence supports safety and effectiveness of the material and application method.

Technological Characteristics

Material: Ti6Al4V titanium alloy per ASTM F136-02a (DIN ISO 5832-3). Dimensions: 2.0 mm shaft diameter, 4.0 mm head diameter, 10-16 mm lengths. Features: Self-tapping/self-drilling, grooved head for wire/band attachment, tapered inner hexagonal drive. Sterilization: Steam (pre-vacuum, 132°C, 4 min hold, 10 min dry) validated per ISO 14937:2000.

Indications for Use

Indicated for temporary fixation of the maxilla and mandible to provide indirect stabilization of fractures of the maxilla, mandible, or both in patients requiring intermaxillary fixation.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Synthes (USA) IMF Screws (K010527)
• Lorenz IMF Screws (K983728)
• KLS-Martin MMF Screw (K980760)
• Leibinger IMF Screws (K963030)

Submission Summary (Full Text)

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Traditional 510(k) - DZL

Medicon eG

.

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# JUN 1 5 2005

## 2.3 Device Names: [807.92(a)(2)]

| Device Names: [807.92(a)(2)] | |
|------------------------------|-------------------------------|
| Proprietary | MEDICON IMF-Orion Screws |
| Common | Small Bone Screw |
| Classification | Screw, Fixation, Intraosseous |

- 2.4. Reason for Submission: [807.81(2)] New Device
## 2.5 Predicate Device [807.92(a)(3)]

| Manufacturer | Synthes (USA); Paoli.<br>K010527 |
|------------------|--------------------------------------------------------------------------------|
| Proprietary Name | Synthes (USA) IMF Screws |
| Catalogue #'s | "IMF Screw Set" GP1852-B<br>see exhibit 4a |
| Manufacturer | Walter Lorenz Surgical, Inc.<br>K983728 |
| Proprietary Name | Lorenz IMF Screws |
| Catalogue #'s | « 2.0/2.4 MANDIBULAR FRACTURE SYSTEM »<br>00-2117, p. 4<br>see exhibit 4b |
| Manufacturer | KLS-Martin L.P.<br>K980760 |
| Proprietary Name | KLS-Martin MMF Screw |
| Catalogue #'s | « FAST-FIX IMF-SYSTEM » 90-848-02<br>see exhibit 4c |
| Manufacturer | Howmedica Leibinger, Inc.<br>K963030 |
| Proprietary Name | Leibinger IMF Screws |
| Catalogue #'s | « IMF Screw System for Intermaxillary Fixation »<br>90-01590<br>see exhibit 4d |

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### 2.6 Device Description [807.92(a)(4)]

The MEDICON IMF-Orion Screws are available in different lengths. Threadlengths within the range of 10.0, 12.0, 14.0 mm and 16.0 mm. The diameter of the shafts is 2.0 mm.

The head shape is in a diameter of 4.0 mm. It is grooved for fastening of wires and rubber bands. For a self-retaining fit to the blade the top is tapered inner hexagonal. The screws are manufactured of Ti6Al-4V according to ASTM F 136-02a.

The MEDICON IMF-Orion Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes. These screws may be applied prior to or after exposure of the fracture.

The shapes, sizes and materials used are substantially equivalent to those of SE devices

### 2.7 Intended Use: [807.92 (a)(5)]

The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, mandible or both.

#### 2.8 Environment of Use

The MEDICON IMF-Orion Screws are intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers.

Within these facilities the MEDICON IMF-Orion Screws may be located in areas where sterile surgical/dental instruments are used such as operating rooms for surgery.

#### 2.9 Difference in Design and Technological Characteristics when Compared to SE Devices [807.92(a)(6)]

- Material: Like the SE devices, the MEDICON IMF-Orion Screws are manufactured from nonmagnetic, high quality Titanium Alloy (Ti6Al4V) acc. to ASTM F136-02a (DIN ISO 5832-3).
- The design is very similar. Both MEDICON and SE devices Design: consist of various sizes regarding length, measurement and fitting of the screw head.

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#### Discussion of Safety and Effectiveness [807.92(b)] 2.10

Clinical results of the MEDICON IMF-Orion Screws made out of Titanium Alloy (Ti6Al4V) and manufactured after ASTM F136-02a have shown their safety and effectiveness:

- 1. see exhibit 5a: German Literature OP-Journal 2003 "Verwendung von IMF-Schrauben zur mandibulo-maxillären Fixation"
- 2. see exhibit 5b: German Literature with English abstract p. 361 "Die FAMI-Schraube für die temporäre intermaxillare Fixation"
- 5c: Literature Addenbrooke's NHS "THE exhibit 3. see INTERMAXILLARY SCREW -- A DEDICATED BICORTICAL BONE SCREW FOR TEMPORARY INTERMAXILLARY FIXATION"

#### Industry Standards: [807.92 (d)] 2.11

MEDICON certifies compliance with required ISO/EN/ASTM and other device-related standards that apply to the manufacure, packaging, labeling, sterilization, and reprocessing of subject devices including the validation of these processes.

### Substantially Equivalent

#### Information Bearing on the Safety and Effectiveness: 2.12

[807.92 (b)(3)]

The MEDICON IMF-Orion Screws have the same intended use as predicate devices. They are made of identical material according to ASTM F136-02a.

The slight differences in design and size do not adversely affect the safety and effectiveness of this device.

The results of design validation and clinical testing raise no new issues of safety and effectiveness.

2-4

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| | 2.13 Comparison with predicate devices (table) | | | | | |
|--|------------------------------------------------|--|--|--|--|--|
|--|------------------------------------------------|--|--|--|--|--|

| | MEDICON | Walter<br>Lorenz | KLS-Martin | Synthes | Howmedica<br>Leibinger |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------------------------------------------|--------------------------|--------------------------------|--------------------------|
| INTENDED USE:<br>The Medicon IMF Orion Screws are<br>intended for use as a bone screw in<br>temporary fixation of the maxilla and<br>mandible, providing indirect stabilization of<br>fractures of the maxilla, mandible or both. | Yes | Yes | Yes | Yes | Yes |
| METHODS OF STERILIZATION:<br>Steam Sterilization to SAL of 10-6<br>(For Medicon IMF Orion Screws:<br>3 times pre-vacuum, 132° C, holding time 4<br>minutes [full cycle], drying time 10 minutes.<br>Validated according to ISO 14937:2000) | Yes | Yes | Yes | Yes | Yes |
| MATERIAL: | Ti6Al4V ASTM<br>F136-02a | Ti6Al4V ASTM<br>F136-02a | Ti6Al4V ASTM<br>F136-02a | 316-L | Ti6Al4V ASTM<br>F136-02a |
| DESIGN:<br>Color, Coding: | Natural silver | Gold,<br>Blue (5.0mm) | Gold | Natural silver | Gold |
| Thread length (mm) | 10, 12, 14, 16 | 5, 7, 9, 11 | 9, 11, 13, 15 | 8, 12 | 8, 14 |
| Thread function | self-tapping &<br>selfdrilling | selfdrilling (blue<br>colored 5.0mm)<br>self-tapping (7,<br>9, 11) | self-tapping | self-tapping &<br>selfdrilling | Self-tapping |
| Headshape secures fast and safe gripping | Yes | Yes | Yes | Yes | Yes |
| Labeling (Packaging shows indications for<br>screw identification) | Assumed | Assumed | Assumed | Assumed | Assumed |
| manufactured after ASTM F 136-02a<br>see Exhibit 3 | Yes | Yes | Yes | Assumed | Yes |

2-5

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 5 2005

Mr. Joachim Schmid General Manager Medicon, E.G. Gaensaecker 15 Tuttlingen, GERMANY D-78532

Re: K050478

Trade/Device Name: Medicon IMF Orion Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 1, 2005 Received: June 2, 2005

Dear Mr. Schmid:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases and his 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, or to active act (Act) that do not require approval of a premarket the Federal I vou, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providens of a 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 (1 Nr.), It hay of be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Eederal Register.

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### Page 2 - Mr. Schmid

Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements Incall that I DA mas made a aves and regulations administered by other Federal agencies. of the Act of ally I oderal business requirements, including, but not limited to: registration 1 out must comply with and are labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 877), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wifi are in you The FDA finding of substantial equivalence of your device to a premarket notification - 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), 11 you desire specific at 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 may obtain 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/industry/support/index.html.

Sincerely yours,

Querie Y. Michaid DMD

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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## INDICATIONS FOR USE

## 510(k) Number (if known): K050478

.

## Device Name: Medicon IMF Orion Screws

Indications for Use: The Medicon IMF Orion Screws are intended for use as a Indications for USC. The Mediconf inn. Onxilla and mandible, providing indirect bono of fractures of the maxilla, mandible or both.

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

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runoe

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K050478

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