KLS MARTIN DRILL-FREE MMF SCREW

K042573 · KLS-Martin L.P. · DZL · Oct 18, 2004 · Dental

Device Facts

• Record ID: K042573
• Device Name: KLS MARTIN DRILL-FREE MMF SCREW
• Applicant: KLS-Martin L.P.
• Product Code: DZL · Dental
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS-Martin Drill Free® MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

Device Story

The KLS-Martin Drill Free® MMF Screw is an intraosseous fixation screw designed for temporary occlusal and fracture stabilization of the maxilla and mandible. Unlike traditional screws requiring a pre-drilled pilot hole, this device features a self-tapping design, allowing for direct insertion into bone. It is used by surgeons in a clinical or surgical setting to stabilize fractures. The device provides mechanical fixation, aiding in the healing process by immobilizing the fracture site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraosseous fixation screw; self-tapping design; metallic construction; intended for manual surgical implantation; no software or electronic components.

Indications for Use

Indicated for patients requiring maxillomandibular fixation for the stabilization of fractures of the maxilla, mandible, or both.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• KLS Martin MMF Screw (K980760)
• Centre-Drive Drill-Free® Screw (K971297)
• KLS-Martin Ortho Anchorage System (K033483)

Submission Summary (Full Text)

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K042573

#### OCT 1 8 2004 510(K) SUMMARY

:

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato<br>Director RA/QA |
| Date of Summary: | 15 September 2004 |
| Device Name: | KLS Martin Drill Free® MMF Screw |
| Trade Name: | Drill Free® MMF Screw |
| Common Name: | Screw, Fixation, Intraosseous |
| Classification<br>Name and Number: | Intraosseous fixation screw or wire<br>(CFR 872.4880) |
| Regulatory Class: | Class II |
| Predicate Devices: | KLS Martin MMF Screw (K980760) |
| | Centre-Drive Drill-Free® Screw (K971297) |
| | System<br>KLS-Martin<br>Ortho<br>Anchorage<br>(K033483) |
| Intended Use: | The KLS-Martin Drill Free® MMF Screw is<br>intended for use in maxillomandibular fixation<br>to provide stabilization of fractures of the<br>maxilla, mandible, or both. |
| Device<br>Description: | The KLS-Martin Drill Free® MMF Screw<br>provides temporary occlusal and fracture<br>stabilization. These screws may be applied<br>prior to or after exposure of the fracture. |

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## Technological Characteristics:

### Similarities to Predicate

The KLS-Martin Drill Free® MMF Screw is identical in intended use as the KLS Martin MMF Screw (K980760)

The KLS-Martin Drill Free® MMF Screw is identical in application as the Centre-Drive Drill-Free® Screw (K971297) and the KLS-Martin Ortho Anchorage System (K033483)

#### Differences to Predicate

The KLS Martin MMF Screw (K980760) requires a pilot hole to be drilled prior to implantation. The KLS-Martin Drill Free® MMF Screw is a self tapping screw that does not require a pilot hole prior to implantation.

#### Substantial Equivalence:

The KLS-Martin Drill Free® MMF Screw is substantially equivalent in intended use as the KLS Martin MMF Screw (K980760) and is substantially equivalent in application as the Centre-Drive Drill-Free® Screw (K971297) and the KLS-Martin Ortho Anchorage System (K033483)

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2004

Ms. Jennifer Damato Director, Regulatory Affairs Quality Assurance KLS-Martin, L.P. 11239-1 St. John's Industrial Parkway South Jacksonville, Florida 32246

Re: K042573

Trade/Device Name: KLS Martin Drill Free® MMF Screws Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: September 15, 2004 Received: September 21, 2004

Dear Ms. Damato:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the roleronood above and no 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 11 1), 1 mean 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 Eederal Register.

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Page 2 - Ms. Damato

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a substant is a complies with other requirements mean that FDA has made a decemination that 50ar administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by potisted to: positi of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and processforms areating You must comply with an the Act STOC STORES (21 CFR Part 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gTD Part 830); and i and listing (21 CFR Fall 807), laboling (21 CFR 200), and 11 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 82), 542 of t requirements as set form in the quality of stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your device to a This letter will anow you to begin manieting your device of your device to a a premarket nothleation. The PDA milling of sassification 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), If you desire specific advice for your de roo on an also as a subscription of any and prease contact the Other or Ochiphants and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay other general micriminatemational and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ching-Ling, Ph.D.

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):

KLS Martin Drill Free® MMF Screws Device Name:

Indications For Use:

The KLS Martin Drill Free® MMF Screws is intended for use in The NEO Martin Drovide stabilization of fractures of the maxilla, mandible, or both.

Sueen Ruanez

(Division Sign-Off) (Division Sign-Oth), General Hospital, Infection Control, Dental Devices 510(k) Number:

V Prescription Use _ (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)

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