MAXLOCK

K050868 · Orthohelix Surgical Designs, Inc. · HRS · May 27, 2005 · Orthopedic

Device Facts

• Record ID: K050868
• Device Name: MAXLOCK
• Applicant: Orthohelix Surgical Designs, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Repair of osteotomies and fractures of small bones in the hand and feet

Device Story

MaxLock Small Bone System consists of titanium fixation plates and screws for orthopedic surgery. Plates feature X-Cross profile, curvature for anatomical fit, and beveled edges to reduce soft tissue wear; holes are counter-sunk for low-profile screw head seating. Plates are contourable intraoperatively to match bone profile. System used by surgeons for internal fixation of small bone fractures, osteotomies, and arthrodesis. Device provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

Bench testing only. Finite Element Analysis (FEA) was used to confirm performance characteristics and substantial equivalence to predicate devices.

Technological Characteristics

Materials: Titanium Ti-6Al-4V ELI Alloy (ASTM F-136). Components: 10 fixation plates, 38 screws. Features: X-Cross profile, beveled edges, counter-sunk holes, contourable plates. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for repair of osteotomies and fractures of phalanges (hands/feet), metacarpals, metatarsals, carpals, tarsal bones, wrist, and ankle; and arthrodesis of hands, wrists, foot, and ankle.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• DePuy 100 Tubular Plate (K920738)
• KLS Martin Hand Plating System (K040598)

Submission Summary (Full Text)

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K050868

MAY 2 7 2005

ﺑ

#### 510(k) Premarket Notification

MaxLock™ Small Bone System

#### 510(k) SUMMARY

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

OrthoHelix Surgical Designs, Inc. 3975 Embassy Parkway Akron, Ohio 44333 Phone: [phone] Fax: [phone]

| Contact Person: | Edward A. Kroll<br>Representative Consultant for<br>OrthoHelix Surgical Designs, Inc. |
|-----------------|---------------------------------------------------------------------------------------|
|-----------------|---------------------------------------------------------------------------------------|

March 31, 2005 Date Prepared:

#### Name of Device

MaxLock ™ Small Bone System

#### Common or Usual Name

Fixation Plates and Screws

### Classification Name

Single/Multiple Component Metallic Fixation Appliances and Accessories

#### Predicate Devices

DePuy 100 Tubular Plate (K920738) KLS Martin Hand Plating System (K040598)

#### Intended Use

Repair of osteotomies and fractures of small bones in the hand and feet

## Device Description

The Maxlock System includes ten (10) fixation plates and 38 screws. Plates vary in size, number of holes and in configuration. Screws vary in size by diameter and length.

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KC50 868

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MaxLock™ Small Bone System

All plates and screws in the Maxlock System are made from Titanium Ti-6Al-4V ELI Alloy. This material conforms with ASTM F-136 Standard Specification for Wrought Titanium 6AI-4V ELI Alloy for Surgical Implant Applications.

The unique X-Cross Profile and curvature of the plates are intended to better match the patients' anatomy. All edges are beveled to minimize wear on surrounding soft tissue and ligaments. The plates are contourable during surgery, to allow a better fit to the profile of bone. Plate holes are counter-sunk to lower the profile of the screw head and help minimize wear on the surrounding soft tissue and ligaments.

## Performance Data

FEA's confirm that the MaxLock System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 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 a stylized representation of three human profiles facing to the right, stacked on top of each other.

MAY 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthohelix Surgical Designs, Inc. C/o Mr. Edward A. Kroll Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141

Re: K050868 Trade/Device Name: Maxlock™ Small Bone System_ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 4, 2005 Received: April 6, 2005

Dear Mr. Kroll:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ase suated in the encrease) of the enactment date of the Medical Device Amendments, or to conninered pror to they 2011 de vices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may or subject to basil as a suble to and the 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 r reaso be aar made a determination that your device complies with other requirements of the Act that I Dr Hao Intact a and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 - Mr. Edward A. Kroll

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This letter will anow you to organ maing of substantial equivalence of your device to a legally premaired predicate device 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), please If you desire specific acrice for Jour as 10 [phone]. Also, please note the regulation entitled, comaci the Office of Complanes at (21 t 7 = 1 = 1 = 1 = 1 = 1 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Stipt. Clude

Dr. Miriam C. Provost, Ph.D.

Provost. F Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): TBD

Device Name: MaxLock™ Small Bone System

Indications for Use:

The MaxLock Small Bone System is indicated for the repair of osteotomies and fractures of:

- Phalanges of the hands and feet. .
- Metacarpals and metatarsals. .
- Carpals and tarsal bones. .
- The wrist and ankle and, .
- Arthrodesis of the hands, wrists, foot and ankle. .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of (

Stypt Rurda

(Division Division of General, Restorative, and Neurological Devices

510(k) Number ... KOSO 868