(91 days)
No
The device description focuses on a mechanical, modular external fixation system with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not algorithm validation.
Yes
The device is described as a system for "treatment and fixation" of various orthopedic conditions, including fractures, contractures, pseudoarthrosis, and for limb lengthening and deformity correction, which aligns with the definition of a therapeutic device.
No.
The document describes the device as an external fixation system used for treatment and fixation of various orthopedic conditions, not for diagnosis. Its intended use focuses on physical intervention and correction (e.g., fracture fixation, limb lengthening, deformity correction).
No
The device description clearly states it is a "modular, ring-based, external fixation system" utilizing physical components like pins, wires, rings, and connecting rods made of various materials. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Stryker Hoffmann LRF System is a modular, ring-based, external fixation system used for the treatment and fixation of orthopedic conditions of the limbs. It involves physically connecting the bone to the system with pins and wires.
- Lack of Biological Sample Analysis: There is no mention of this device analyzing any biological samples from the patient. Its function is purely mechanical and structural for external fixation.
Therefore, the Stryker Hoffmann LRF System falls under the category of a surgical or orthopedic device, not an in vitro diagnostic device.
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 and utilizes 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
Not Found
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:
Comparative mechanical testing to the predicate system demonstrated substantial equivalence.
The following tests were performed:
- Corrosion Test
- Self-holding Function Test Over Time
- Pullout Test.
Clinical Testing:
Clinical testing was not required to be provided for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hoffmann LRF System, K163656
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 25, 2019
Stryker GmbH Jackie Perri Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K182968
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: January 10, 2019 Received: January 11, 2019
Dear Ms. Perri:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Peter G. | Digitally signed by
Peter G. Allen -S |
|----------|------------------------------------------|
| Allen -S | Date: 2019.01.25
10:05:56 -05'00' |
FOR 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) K182968
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter: | Stryker GmbH
Bohnackerweg l
CH-2545 Selzach
Switzerland |
|-----------------------|-----------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackie Perri
Regulatory Affairs Specialist
Phone: (732) 770-5616
Email: jackie.perri@stryker.com |
| Date Prepared: | October 2, 2018 |
| 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) |
| Requlatory Class: | Class II |
| Product Code: | KTT |
| Primary Predicate: | Hoffmann LRF System, K163656 |
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 and utilizes 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.
Indications for Use:
The Stryker Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:
4
- 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:
Comparison of subject and predicate systems demonstrated a shared use of material, fundamental design, and general operating principles in support of the claim of substantial equivalence.
Performance Data:
Non-Clinical Testing
Comparative mechanical testing to the predicate system demonstrated substantial equivalence.
The following tests were performed:
- Corrosion Test
- Self-holding Function Test Over Time
- Pullout Test .
Clinical Testing
Clinical testing was not required to be provided for this submission.
Conclusion:
With the exception of the modifications described in the Executive Summary, the Hoffmann LRF System described in this submission is identical to the previously cleared and primary predicate, K163656. Mechanical testing demonstrated that subject system performs as intended and at least as well as the predicate. Based on these attributes, the subject system is deemed substantially equivalent.