(29 days)
Not Found
No
The document describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction, which are direct treatments for medical conditions.
No
The device description and intended use indicate it is an external fixation system used for treating and fixing orthopedic conditions, not for diagnosing them.
No
The device description clearly states it is a modular, ring-based, external fixation system with components manufactured from stainless steel, aluminum, PEEK, and carbon fiber, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a device used for the physical fixation and manipulation of bones and soft tissues in the body (fractures, fusions, limb lengthening, etc.). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a modular external fixation system with pins, wires, and rings that connect to the bone. This is a mechanical device used for external support and manipulation.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these types of samples.
In summary, the Hoffmann LRF System is a medical device used for orthopedic treatment and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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
Product codes
KTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs
Indicated Patient Age Range
pediatric patients and adults
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hoffmann LRF System (K203568)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
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.
1
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).
2
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)
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 GmbH
Bohnackerweg 1
CH-2545 Selzach
Switzerland |
|-----------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Amy Noccioli
Staff Regulatory Affairs Specialist
Phone: (860) 463-9945
Fax: (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 and
accessories (21 CFR § 888.3030) |
| Regulatory Class: | Class II |
| Product Code: | KTT |
| Primary Predicate: | Hoffmann LRF System (K203568) |
System 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.
Intended Use:
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.
5
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.