Hoffmann LRF (Limb Reconstruction Frame) System

K153377 · Stryker GmbH · KTT · Apr 11, 2016 · Orthopedic

Device Facts

• Record ID: K153377
• Device Name: Hoffmann LRF (Limb Reconstruction Frame) System
• Applicant: Stryker GmbH
• Product Code: KTT · Orthopedic
• Decision Date: Apr 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hoffmann LRF System is intended for fixation of fractures, ioint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.

Device Story

Modular, ring-based external fixation system; treats orthopedic limb conditions. Uses pins and wires to connect bone to frame; rings placed statically or manipulated gradually to correct deformity or lengthen bone. Subject submission adds transport strut, end cap, safety clip, and lengthening ruler for bone lengthening/transport. Used in clinical settings by orthopedic surgeons. Provides mechanical stabilization and distraction/compression forces to bone segments; facilitates bone healing and reconstruction. Benefits patients by enabling complex limb salvage and deformity correction.

Clinical Evidence

No clinical data was performed or required. Substantial equivalence is supported by non-clinical comparative mechanical testing, including static and dynamic four-point bending, static cantilever bending, dynamic cantilever bending, and static/dynamic compression testing.

Technological Characteristics

Modular, ring-based external fixation frame. Materials: steel, aluminum, PEEK, carbon fiber. Principle: mechanical stabilization and distraction via pins and wires. Components: transport strut, end cap, safety clip, lengthening ruler. Provided non-sterile. No software or electronic components.

Indications for Use

Indicated for pediatric and adult patients for treatment/fixation of open/closed fractures, post-traumatic joint contracture, fractures/disease causing contracture or requiring distraction, pseudoarthrosis/non-union, limb lengthening, bony/soft tissue deformity or defect correction, joint arthrodesis, comminuted intra-articular distal radius fractures, and bone transport. Additionally indicated for adults for osteotomy, revision procedures, bone reconstruction, foot fusions/replantations, Charcot foot reconstruction, and Lisfranc dislocations.

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 LRF System (K140961)
• External Fixation System (Ilizarov) (K031181)

Reference Devices

• Monticelli-Spinelli External Fixation System
• Apex Pins
• Trauma Pelvic Set
• Hoffmann II External Fixation System
• Hoffmann 3 External Fixation System
• Hoffmann II External Fixation System 90° Post
• Hoffmann II Miami Post
• Hoffmann II Carbon Connecting Rods
• Hoffmann II MRI External Fixation System
• Hoffmann II Compact MRI External Fixation System

Submission Summary (Full Text)

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Image /page/0/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 three human profiles facing to the right, stacked one in front of the other. The profiles are rendered in a simple, abstract style.

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

April 11, 2016

Stryker Gmbh Mr. Paul Nelson Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K153377 Trade/Device Name: Hoffmann LRF System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 11, 2016 Received: March 14, 2016

Dear Paul Nelson:

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 misleading.

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 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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. Melkerson -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K153377

Device Name Hoffmann LRF System

Indications for Use (Describe)

The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:

- Open and Closed Fractures
- · Post-traumatic joint contracture which has resulted in loss of range of motion
- · Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- · Pseudoarthrosis or non-union of long bones
- · Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
- · Correction of bony or soft tissue deformity
- · Correction of segmental bony or soft tissue defects
- · Joint arthrodesis
- · Management of comminuted intra-articular fractures of the distal radius
- · Bone transport

The Hoffmann LRF System is indicated in adults for:

- · Osteotomy
- · Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- · Fusions and replantations of the foot
- · Charcot foot reconstruction
- · Lisfranc dislocations

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) Summary

| Submitter: | Stryker GmbH<br>Bohnackerweg 1<br>CH-2545 Selzach<br>Switzerland |
|---------------------------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Paul Nelson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | November 20, 2015 |
| Name of Device: | Hoffmann LRF System |
| Common or Usual Name: | External Fixation Device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (21 CFR § 888.3030) |
| Regulatory Class: | Class II |
| Product Code: | KTT |
| Primary Predicate:<br>Additional Predicate: | Hoffmann LRF System, K140961<br>External Fixation System (Ilizarov), K031181 |

#### Device Description:

Hoffmann LRF (Limb Reconstruction Frame) System is a modular, rinq-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. This system utilizes steel, aluminum, PEEK, and carbon fiber.

This submission extends K140961 by introducing a new strut and associated components. This strut can be used in all Hoffmann LRF applications that do not require the use of a foot ring, but are specifically designed for bone lengthening and bone transport. Total components added to the Hoffmann LRF System with this submission: Transport Strut, Bone Transport Strut End Cap, Safety Clip, and Lengthening Ruler, all of which are single-use, and a Tray, which is multi-use. All are provided nonsterile.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System, Hoffmann II External Fixation System 90° Post, Hoffmann II Miami Post, Hoffmann II Carbon Connecting Rods, Hoffmann II MRI External Fixation System, and Hoffmann II Compact MRI External Fixation System.

Use of these components does not confer MRI compatibility to the Hoffmann LRF system.

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#### Intended Use:

The Hoffmann LRF System is intended for fixation of fractures, ioint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.

#### Indications for Use:

The Stryker Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:

- . Open and Closed Fractures
- Post-traumatic joint contracture which has resulted in loss of range of motion
- . Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Pseudoarthrosis or non-union of long bones
- Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
- . Correction of bony or soft tissue deformity
- Correction of segmental bony or soft tissue defects
- . Joint arthrodesis
- . Management of comminuted intra-articular fractures of the distal radius
- . Bone transport

The Hoffmann LRF System is indicated in adults for:

- Osteotomy
- . Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures .
- . Fusions and replantations of the foot
- . Charcot foot reconstruction
- . Lisfranc dislocations

## Comparison of Technological characteristics with the Predicate Devices:

The subject Hoffmann LRF, predicate Hoffmann LRF, and Ilizarov systems share common materials and utilize the same general principles of operation. All bones involved with the correction are bound to, and manipulated by, an external, ring-based frame system through a series of pins and wires. Corrections are communicated to the bone through this system of connections via a prescribed protocol of stabilization, or gradual movements.

The subject and predicate devices share the following technological characteristics:

- . External, ring-based frame approach
- . Pins and wires connecting bone to frame
- . Similar materials

The subject and predicate devices have the following dissimilar technological characteristics:

- . Method by which rings can be moved vertically
- . Ability to anqulate rings

## Performance Data:

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#### Non-Clinical Testing

Comparative mechanical testing to the llizarov predicate system demonstrated substantial equivalence.

The following component tests were performed:

- Static four-point bending .
- Dynamic four-point bending .
- Static cantilever bending .
- . Dynamic cantilever bending

The following frame construct tests were performed:

- Static compression
- Dynamic compression .

#### Clinical Testing

Clinical testing was not performed, or required, for this submission.

#### Conclusion:

With the exception of the strut and associated components, the Hoffmann LRF system in this submission is exactly the same as the previously cleared, and primary predicate, system, K140961. Compared to the llizarov additional predicate, K031181, the subject system shares the same intended use, patient population, and principles of operation, as well as similar materials and technological characteristics. Mechanical testing demonstrated that the subject system performs as intended and at least as well as the predicate. Based on these attributes, the subject device is deemed substantially equivalent.