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

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.

AI/ML Overview

The provided text is a 510(k) summary for the Hoffmann LRF System and does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical mechanical testing.

Here's an breakdown of the relevant sections without the requested information:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes mechanical tests performed but does not list specific acceptance criteria or quantitative performance outcomes against those criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Comparative mechanical testing," "component tests," and "frame construct tests." However, it does not specify the sample sizes used for these tests or the data provenance. It states "Clinical testing was not performed, or required, for this submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not applicable as clinical testing was not performed, and ground truth in the context of expert consensus is not mentioned for mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as clinical ground truth establishment is not relevant to the described mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical medical device (an external fixation system), not an AI-assisted diagnostic or treatment tool. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the mechanical tests. For physical devices, "ground truth" would typically refer to established engineering standards or reference measurements. The document states "Mechanical testing demonstrated that the subject system performs as intended and at least as well as the predicate," implying a comparison to the predicate's performance.

8. The sample size for the training set: Not applicable, as this is a physical medical device and not an AI/machine learning model.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is present in the document regarding performance:

Non-Clinical Testing:
- Types of tests:
  - Component tests: Static four-point bending, Dynamic four-point bending, Static cantilever bending, Dynamic cantilever bending.
  - Frame construct tests: Static compression, Dynamic compression.
- Purpose: To demonstrate substantial equivalence to the Ilizarov predicate system (K031181).
- Conclusion: "Mechanical testing demonstrated that the subject system performs as intended and at least as well as the predicate."
Clinical Testing: "Clinical testing was not performed, or required, for this submission."

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 GmbHBohnackerweg 1CH-2545 SelzachSwitzerland
Contact Person:	Paul NelsonRegulatory Affairs SpecialistPhone: (201) 831-5691Fax: (201) 831-6500
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 andaccessories (21 CFR § 888.3030)
Regulatory Class:	Class II
Product Code:	KTT
Primary Predicate:Additional Predicate:	Hoffmann LRF System, K140961External Fixation System (Ilizarov), K031181

Device Description:

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.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.