EXACTECH STERILE MODULAR DRILL BIT

K960720 · Exactech, Inc. · HWE · Apr 23, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960720
• Device Name: EXACTECH STERILE MODULAR DRILL BIT
• Applicant: Exactech, Inc.
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Apr 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1

Intended Use

The Sterile Modular Drill Bit is indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement

Device Story

The Exactech Sterile Modular Drill Bit is a surgical instrument used in orthopedic procedures to predrill bone for screw placement. The device consists of modular drill bits (available in long and short versions) featuring a 120° point angle for bone cutting and a 30° helix angle for debris removal. It utilizes a high-tolerance press-fit cross pin and a bayonet-style locking mechanism for assembly with flexible or fixed-angle drivers. The device is operated by surgeons in a clinical/OR setting. It is supplied sterile via gamma irradiation. The device facilitates bone preparation, aiding in the secure placement of orthopedic screws.

Clinical Evidence

No clinical data. Bench testing and design specifications provided to demonstrate equivalence.

Technological Characteristics

Constructed of Custom 455® stainless steel. Features 120° point angle and 30° helix angle. Modular design with press-fit cross pin and bayonet locking mechanism. Sterilized via gamma irradiation per AAMI guidelines.

Indications for Use

Indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• DePuy Drill Bit

Submission Summary (Full Text)

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001
K 960720
APR 23 1996

SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION
FOR THE PREMARKET NOTIFICATION FOR THE
Exactech Sterile Modular Drill Bit

K 960720

Exactech®, Inc.
Establishment Registration Number 1038671

4613 NW 6th Street
Gainesville, FL 32609
Tel: [phone]
Fax: [phone]

Contact Person: Martha C. Miller
Director Regulatory Affairs

*Exactech Sterile Modular Drill Bit*

The Exactech Sterile Modular Drill Bit is made of similar materials and is of a similar design to devices that were on the market before May 28, 1976. Additionally, the Sterile Drill Bit is of a similar design to other devices on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include, but are not limited to:

- DePuy Drill Bit

Similarities/Dissimilarities:

The DePuy drill system is similar to the Exactech system in that the cross pin in the bit and the bayonet locking mechanism operate in a like fashion. The flex shafts are both multiple wrapped springs. They differ in the diameters and lengths of the bits that are offered in the system. The DePuy flex shaft is slightly longer and the Exactech flex shaft is slightly stiffer. The DePuy shaft has a Hudson locking end and the Exactech flex shaft has a Trinkle locking end. The 45° fixed angle drivers are similar in all fashions.

Exactech, Inc. has supplied advertisements, brochures and/or catalog information from these companies to the FDA as evidence of equivalency. This literature is in the public domain. In addition, Exactech has provided the FDA design drawings, material specifications and photos of the Sterile Modular Drill Bit.

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1. Classification

This device is appropriately placed in FDA classification:

Drill: Bit, Drill. Number 87HTW, Class I device, under 21 CFR 888.4540.

2. Common Name: Drill Bit

3. Trade Name: Exactech Sterile Modular Drill Bit

4. Device Description

The Exactech Sterile Drill Bit is intended for use in orthopedic procedures for drilling bone. The drill bit is designed with a 120° point angle for smooth, effective, bone cutting. The 30° helix angle maintains strength, but provides an efficient channel by which cut bone may escape. The outer diameter (OD) tolerance and associated drill bit guide geometry minimize drill bit damage.

The five (5) modular bits are designed in long and short versions. They have a high tolerance press fit cross pin that provides easy assembly and disassembly with positive bayonet style locking capability in both the flexible and fixed angle drill bit drivers.

All bits are constructed of 455 stainless steel for strength, hardness and resistance to wear.

5. Material Specifications

The Sterile Drill Bits are constructed of Custom 455® stainless steel.

6. Mechanical Properties

Typical mechanical properties can be found in the Carpenter Technology manual: Custom 455® Stainless section.

7. Sterilization

The Exactech Sterile Drill Bits will be supplied sterile. They will be sterilized in their final, sealed packages by gamma irradiation at a contract sterilization facility. The sterilization protocol will be based on the Guidelines for Radiation Sterilization of Medical Devices, issued by the Association for Advancement of Medical Instrumentation Process Control.

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# Indications:

The Sterile Modular Drill Bit is indicated for use in general orthopedic procedures to predrill bone in preparation for bone screw placement

# Manufacturing/Packaging/Sterilization Sites:

# Manufacturing/Packaging:

| Exactech® Inc.
4613 NW 6th Street
Gainesville, FL 32609
Phone: [phone]
Fax: [phone] | FDA Establishment No: 1038671 |
| --- | --- |

# Contract Sterilization Sites:

| Sterigenics International
305 Enterprise Drive
Westerville, Ohio 43081-8827
Phone: [phone]
Fax: [phone] | FDA Establishment No: 1526534 |
| --- | --- |
| Sterigenics International
18011 Withers Cove Park Drive
Charlotte, North Carolina 28273
Phone: [phone]
Fax: [phone] | FDA Establishment No: 1058584 |
| --- | --- |

# Applicant or Sponsor:

| Exactech®, Inc.
4613 NW 6th Street
Gainesville, FL 32609 | FDA Establishment No: 1038671 |
| --- | --- |

# Contact Person:

Martha C. Miller<br/>
Director, Regulatory Affairs<br/>
Telephone: [phone]<br/>Fax: [phone]