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

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

Device Description

The Hoffmann LRF System is a modular, ring-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. The system components are manufactured from stainless steel, aluminum, PEEK, and carbon fiber.

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

This document is a 510(k) Premarket Notification from the FDA regarding the Hoffmann LRF System. It states that the device is substantially equivalent to a previously marketed predicate device (K203568).

The crucial information for addressing your request, particularly regarding acceptance criteria and performance studies, is explicitly absent.

Here's why and what can be inferred:

No Acceptance Criteria or Performance Data Presented: The document states under "Performance Data":
- "Non-Clinical Testing: No performance testing is necessary to support the claim of substantial equivalence."
- "Clinical Testing: No clinical testing is necessary to support the claim of substantial equivalence."

This means that for this specific 510(k) submission (K233741), the FDA's clearance was based on the device's substantial equivalence to a predicate device (K203568), rather than requiring new, specific performance study data or predefined acceptance criteria to be met for this submission. The change from the predicate device is noted as a "dimensional change to the struts."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not provided in the supplied text. The FDA's decision was based on a comparison to an already cleared device, implying that the performance and safety characteristics were considered to be sufficiently similar, and no new studies were deemed necessary for this particular submission.

In summary, based only on the provided text, the answer to all your specific questions regarding acceptance criteria and study details is that this information is not available within this 510(k) submission document.

Summary

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December 21, 2023

Stryker GmbH Amy Noccioli Staff Regulatory Affairs Specialist Bohnackerweg 1 Ch-2545. Selzach Switzerland

Re: K233741

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: November 22, 2023 Received: November 22, 2023

Dear Amy Noccioli:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely, Lixin Liu -S

Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233741

Device Name

Hoffmann LRF System

Indications for Use (Describe)

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

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

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:	Amy NoccioliStaff Regulatory Affairs SpecialistPhone: (860) 463-9945Fax: (201) 831-6020
Date Prepared:	December 20, 2023
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:	Hoffmann LRF System (K203568)

System Description:

Intended Use:

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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:

A comparison of the subject and predicate systems demonstrates that, while there is a dimensional change to the struts, the subject and predicate devices have material, fundamental design, and general operating principles.

Performance Data:

Non-Clinical Testing

No performance testing is necessary to support the claim of substantial equivalence.

Clinical Testing

No clinical testing is necessary to support the claim of substantial equivalence.

Conclusion:

Except for the modification to the struts, the Hoffmann LRF System described in this submission is identical to the previously cleared Hoffmann LRF System (K203568). The subject system has similar technological characteristics and the same intended use, patient population, principles of operation, and materials as the predicate system. Based on these attributes, the subject system is deemed substantially equivalent to the predicate device.

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.