(56 days)
No
The description focuses on the mechanical and modular aspects of an external fixation system. There is no mention of AI, ML, or any software functionality beyond basic validation.
Yes
The device is an external fixation system used for the treatment and fixation of various orthopedic conditions, including fractures, bone deformities, and limb lengthening, which are therapeutic interventions.
No
The provided text explicitly states the device's intended use is for "treatment and fixation" and describes it as an "external fixation system." It does not mention any diagnostic capabilities.
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. While software validation is mentioned, it pertains to expanded functionality of a system that is fundamentally hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests 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 provided information clearly describes the Sever Hoffmann LRF System as a modular, ring-based, external fixation system used for the treatment and fixation of orthopedic conditions of the limbs. It involves physically connecting to the bone with pins and wires for purposes like fracture fixation, limb lengthening, deformity correction, etc.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its function is purely mechanical and therapeutic.
Therefore, based on the provided information, the Sever Hoffmann LRF System is a surgical device used for orthopedic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sever 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
Non-Clinical Testing: Software validation was performed on the expanded functionality.
Clinical Testing: Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
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
February 1, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker GmbH Sanja Jahr Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K203568
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: December 4, 2020 Received: December 7, 2020
Dear Sanja Jahr:
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. 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/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 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 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).
Sincerely,
Ting Song 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K203568
Device Name Hoffmann LRF System
Indications for Use (Describe)
The Sever 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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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3
510(k) Summary
| Submitter: | Stryker GmbH
Bohnackerweg l
CH-2545 Selzach
Switzerland |
|-----------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Sanja Jahr
Staff Regulatory Affairs Specialist
Phone: (201) 831-6797
Fax: (201) 831-6020 |
| Date Prepared: | December 4th, 2020 |
| 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, K182968 |
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:
In support of the claim of substantial equivalence the comparison between the subject and predicate system demonstrate a shared use of material, fundamental design, and general operating principles.
Performance Data:
Non-Clinical Testing
Software validation was performed on the expanded functionality.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion:
With the exception of the newly added software updates, the Hoffmann LRF System described in this submission is identical to the previously cleared Hoffmann LRF (K182968). The subject system shares the same intended use, patient population, principles of operation, technological characteristics and materials to the primary predicate Hoffmann LRF (K182968). Non-clinical testing was not required as part of this submission. Based on these attributes, the subject system is deemed substantially equivalent.