HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT

K022651 · Howmedica Osteonics Corp. · LXT · Oct 17, 2002 · Orthopedic

Device Facts

• Record ID: K022651
• Device Name: HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
• Applicant: Howmedica Osteonics Corp.
• Product Code: LXT · Orthopedic
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This submission describes an external fixation frame component when used together with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax " External Fixation System and in conjunction with Apex® Pins, creates an external fixation construct. External fixation frames provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

Device Story

Hoffmann® 30 Degree Pelvic Double Ball Joint is an external fixation frame component; modification of Hoffmann® 5 Hole Ball Joint. Features lengthened clamp, additional ball joint, modified pin interface, and 30-degree tilt in pin-holding portion. Used in OR by surgeons to construct external fixation frames for bone stabilization. Integrates with Hoffmann®, Hoffmann® II, Monotube® TRIAX systems, and Apex® Pins. Provides mechanical support for fracture management; enables stabilization in complex anatomical scenarios where internal fixation is contraindicated due to soft tissue status.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation component. Design features: 30-degree angled pin-holding clamp, dual ball joint mechanism, and modified pin interface. Materials and sterilization methods are consistent with the predicate Hoffmann® 5 Hole Ball Joint system. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring stabilization of open and/or unstable fractures, osteotomy, arthrodesis, correction of deformity, revision procedures, or bone reconstruction where soft tissue injury precludes internal fixation methods like IM rods or casts.

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

• Hoffmann® 5 Hole Ball Joint

Submission Summary (Full Text)

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K022651 PAGE 1/1

# OCT 1 7 2002

510(k) Premarket Notification

## 510(k) Summary of Safety and Effectiveness for the Hoffmann® 30 Degree Pelvic Double Ball Joint

| Proprietary Name: | Hoffmann® 30 Degree Pelvic Double Ball Joint |
|-----------------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | External Fixation Frame Component |
| Classification Name and Reference | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 LXT |
| For Information contact: | Karen Ariemma, Regulatory Affairs Specialist |
| | Howmedica Osteonics Corp. |
| | 59 Route 17 |
| | Allendale, NJ 07401-1677 |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Summary Prepared: | August 8, 2002 |

Intended Use:

This submission describes an external fixation frame component when used together with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System and Monotube Triax " External Fixation System and in conjunction with Apex® Pins, creates an external fixation construct. External fixation frames provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.

#### Description:

The subject Hoffmann® 30 Degree Pelvic Double Ball Joint is a modification of the Hoffmann® 5 Hole Ball Joint. The modification involves lengthening the clamp, adding an additional ball joint, modifying the pin interface and tilting the pin holding portion of the clamp by 30 degrees.

#### Substantial Equivalence:

Equivalency of this device is based on similarities in intended use, materials and design to the Hoffmann® 5 Hole Ball Joint. Testing has been conducted on the Hoffmann® 30 Degree Pelvic Double Ball Joint demonstrating substantial equivalence to the predicate Hoffmann® 5 Hole Ball Joint.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CT 1 7 2002

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

> K022651 Hoffmann® 30 Degree Pelvic Double Ball Joint Trade Name: 21 CFR 888.3030 Regulation Number: Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II LXT Product Code: August 8, 2002 Dated: August 9, 2002 Received:

Dear Ms. Ariemma:

Re:

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.

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 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 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); 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.

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Page 2 – Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsmamain.html.

Sincerely yours,

l. Mark N-Millican

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): K122651

Device Name: Hoffmann® 30 Degree Pelvic Double Ball Joint

:

Indications For Use:

The Hoffmann® 30 Degree Pelvic Double Ball Joint is intended to be used with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX " External Fixation System and in conjunction with Apex Pins. This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation. The indications for use of external fixation devices include:

- Bone fracture fixation .
- Osteotomy .
- . Arthrodesis
- . Correction of deformity
- Revision procedure where other treatments or devices have been unsuccessful ●
- Bone reconstruction procedures .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| (k) Number | K022657 |
|------------|---------|
|------------|---------|