ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

K102743 · Ortho Solutions Limited · HWE · Jan 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K102743
• Device Name: ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
• Applicant: Ortho Solutions Limited
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Jan 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

Device Story

Ortho Solutions Sterile Drill Bits are single-use, sterile surgical instruments designed to bore holes into bone. The device consists of stainless steel bits available in various sizes, lengths, and configurations (solid or cannulated), featuring a fluted design and various end coupling mechanisms. The bits are used by surgeons in clinical settings to prepare bone sites for the insertion of orthopedic fixation hardware (screws, wires, cables, plates, pins, bolts). The device is provided sterile via gamma radiation. The drill bits function as mechanical accessories for surgical instrument motors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel (cold-worked or heat-treated). Design: Fluted, solid or cannulated, various sizes/lengths, various end coupling mechanisms. Sterilization: Gamma radiation. Energy source: Mechanical (powered by surgical instrument motors).

Indications for Use

Indicated for use in orthopedic surgical procedures requiring the boring of holes into bone for the subsequent insertion of fixation hardware such as screws, wires, cables, plates, pins, or bolts.

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

• Synthes Sterile Drill Bits (K962913)

Submission Summary (Full Text)

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Ortho Solutions Limited - K102743 510(k) Summary:

JAN 2 0 2011

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### 510(k) Summary of Safety and Effectiveness

#### SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

510(K) Summary

- Ortho Solutions Limited NAME OF FIRM: West Station Buisness Park Spital Road Maldon ESSEX, CM9 6FF United Kingdom 510(k) FIRM CONTACT: Al Lippincott Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, MN 55372 Telephone No: 952-492-5858 E-mail: [e-mail] September 13, 2010 DATE: Ortho Solutions Sterile Drill Bits TRADE NAME: Sterile Single-Use - Drill Bits COMMON NAME: CLASSIFICATION: Surgical instrument motors and accessories/attachments (see 21 CFR Sec. 878.4820) DEVICE PRODUCT CODE: HWE GFF, HSZ, GFA SUBSEQUENT PRODUCT CODE:
Synthes Sterile Drill Bits (K962913) SUBSTANTIALLY EQUIVALENT DEVICES

All Ortho Solutions Sterile Single-Use Drills Bits are manufactured DEVICE DESCRIPTION: from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.

INTENDED USE: Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

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Ortho Solutions Limited - K102743 510(k) Summary:

The Ortho Solutions Sterile Drill Bits are Substantially Equivalent EQUIVALENCE: (SE) to the Synthes K962913 Sterile Drill Bits.

SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS

The Ortho Solutions Sterile Drill Bits are identical in Material, Geometry Design/Markings, and Indications to the Synthes Sterile Drill Bits.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ortho Solutions Limited % Engineering Consulting Services, Inc. Mr. Al Lippincott 3150 East 200th Street Prior Lake, Minnesota 55372

JAN 2 0 201

Re: K102743

Trade/Device Name: Ortho Solutions Sterile Drill Bits Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: Class II Product Code: HWE, GFF, HSZ, GFA Dated: December 20, 2010 Received: December 27, 2010

Dear Mr. Lippincott:

.

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 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misJeading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can 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 Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. Al Lippincott

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Mello

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the text "ORTHO (S) SOLUTIONS". The word "ORTHO" is in all caps and is followed by a large, bold "S" enclosed in a circle. The word "SOLUTIONS" is also in all caps and is placed after the circled "S". The font appears to be a serif typeface.

West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Tel: [phone] Fax: [phone] Email: [e-mail] www.orthosolutions.com

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# Indications for Use

## 510(k) NUMBER: K102743

DEVICE NAME: Ortho Solutions Sterile Drill Bits

## INDICATIONS FOR USE:

Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

Mildredle firmxn

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K|02743

Prescription Use ×

AND/OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Registered Office: West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Registered in England No: 4311933