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 aluminum, carbon fiber, stainless steel, and various polymers. The system also encompasses a web application and mobile application.

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

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Hoffmann LRF System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

December 19, 2025

Stryker Gmbh
Amy Noccioli
Sr. Staff Regulatory Affairs Specialist
Bohnackerweg 1
Selzach
Switzerland

Re: K253202
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, JDW
Dated: September 26, 2025
Received: September 26, 2025

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.

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"

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(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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K253202

Device Name
Hoffmann LRF System

Indications for Use (Describe)

The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult patients 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Page 5

510(k) Summary

Submitter: Stryker GmbH
Bohnackerweg 1
CH-2545 Selzach
Switzerland

Contact Person: Amy Noccioli
Sr. Staff Regulatory Affairs Specialist
Phone: (860) 463-9945
Fax: (201) 831-6020

Date Prepared: December 18, 2025

Name of Device: Hoffmann LRF System

Common or Usual Name: External Fixation Device

Product Code: KTT, JDW

Classification Name and Regulation Number:
Single/multiple component metallic bone fixation appliances and accessories
(21 CFR § 888.3030)

Smooth or threaded metallic bone fixation fastener
(21 CFR § 888.3040)

Regulatory Class: Class II

Primary Predicate: Hoffmann LRF System (K233741)

Additional Predicates:

Stryker Apex Pins (K061493)
Stryker RingFix (K071394)
S&N Taylor Spatial Frame (K210953)
Depuy Synthes MAXFRAME (K211313)
Depuy Synthes MAXFRAME AUTOSTRUT (K231922)
S&N Ilizarov Frame (K201353)

System Description:

K253202 (Page 1 of 2)

Page 6

Indications for Use:

The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult patients 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, although there are some technological differences, such as the use of wireless communication and additional hardware components, the subject and predicate devices have the same fundamental design and general operating principles.

Performance Data:

Non-Clinical Testing

Static and dynamic mechanical testing per ASTM 1541-2 and ASTM F382
Electromagnetic compatibility per IEC 60601-1-2
Wireless coexistence per ANSI C63.27
Electrical safety testing per IEC 60601-1
Software verification and validation

Clinical Testing

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

Conclusion:

The subject Hoffmann LRF System has similar technological characteristics and the same intended use, indications for use, patient population, and principles of operation as the predicates. Based on these attributes, the subject system is deemed substantially equivalent to the predicates.

K253202 (Page 2 of 2)

Regulation Number and Section

N/A