(209 days)
Not Found
No
The device description details mechanical components of an external fixation system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not software validation.
Yes
The device is described as an external fixation system used for the treatment and fixation of various conditions such as fractures, joint contractures, pseudoarthrosis, limb lengthening, and deformity correction. These are all therapeutic applications.
No
The device is an external fixation system used for the treatment and fixation of various musculoskeletal conditions, not for diagnosing them.
No
The device description explicitly lists numerous hardware components (rings, rods, struts, bolts, etc.) that constitute the external fixation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment and fixation of fractures, deformities, and other musculoskeletal conditions in pediatric and adult patients. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is described as an external fixation system consisting of various mechanical components (rings, rods, struts, pins, etc.) used to stabilize and manipulate bones. This aligns with a surgical/orthopedic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, urine, etc.) from the human body to provide diagnostic information.
In summary, the Stryker Hoffmann LRF System is a medical device used for external fixation and limb reconstruction, which falls under the category of surgical/orthopedic devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Stryker Hoffmann LRF (Limb Reconstruction Frame) 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 motion and fractures requiring distraction
- Pseudoarthrosis or non-union of long bones
- Limb lengthening by epiphyseal 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
The Stryker 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 (comma separated list FDA assigned to the subject device)
KTT
Device Description
Originally cleared in K113327, the Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolt offset adapters, pin bolts and pin adapters, and washers.
- Modifications to the previously cleared telescopic strut and wire bolt components, as part of the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327, were cleared in K130334.
- Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in K130907 as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327.
- This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the inclusion of additional components to the previously cleared Hoffmann LRF (Limb Reconstruction Frame) System, in K130907. The additional components of this submission will consist of the following: constrained hinge strut, universal hinge strut, motor struts, spherical washer, hinge bolt, self-locking nut, half hinge, universal joint, adjustment instrument, slotted plate and buckle.
This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II, Hoffman II MRI and Hoffmann 3 External Fixation System, and the Apex Fixation Pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the additional components and component compatibility. Testing was performed with compliance to ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device." Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System added components are substantially equivalent to the predicate device components. Testing included the following:
- Static Cantilever Bending Test
- Dynamic Cantilever Bending Test
- Dynamic Frame Testing
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113327, K130334, K130907, K031181
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three overlapping profiles, creating a sense of depth and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2014
Stryker Trauma AG Ms. Nesli Karakaya Associate Regulatory Affairs Manager Bohnackerweg 1 CH-2545 Selzach Switzerland
Re: K140961 Trade/Device Name: Hoffmann LRF (Limb Reconstruction Frame) 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: September 29, 2014 Received: October 8, 2014
Dear Ms. Karakaya:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Ms. Nesli Karakaya
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140961
Device Name
Hoffmann LRF (Limb Reconstruction Frame) System
Indications for Use (Describe)
The Stryker Hoffmann LRF (Limb Reconstruction Frame) 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 motion and fractures requiring distraction
- Pseudoarthrosis or non-union of long bones
- · Limb lengthening by epiphyseal 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
The Stryker 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
| Proprietary Name: | Hoffmann LRF (Limb Reconstruction Frame) System |
|---|---|
| Common Name: | External Fixation Device |
| Classification Name and Reference: | Single/multiple component metallic bone fixation |
| appliances and accessories 21 CFR §888.3030 | |
| Regulatory Class: | Class II |
| Product Codes: | KTT-Appliance, fixation, nail/blade/plate combination |
| multiple components | |
| Sponsor: | Stryker Trauma AG |
| Bohnackerweg 1 | |
| CH-2545 Selzach | |
| Switzerland | |
| Contact Information: | Nesli Karakaya, RAC |
| Associate Regulatory Affairs Manager | |
| Bohnackerweg 1 | |
| CH-2545 Selzach | |
| Switzerland | |
| Phone: +41 32 641 69 30 Fax: +41 32 641 66 60 | |
| nesli.karakaya@stryker.com | |
| Date Prepared: | April 10, 2014 |
Description:
Originally cleared in K113327, the Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolt offset adapters, pin bolts and pin adapters, and washers.
- Modifications to the previously cleared telescopic strut and wire bolt components, as part ● of the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327, were cleared in K130334.
- Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in . K130907 as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327.
- This Traditional 510(k) submission is being supplied to the U.S. FDA to provide ● authorization to market the inclusion of additional components to the previously cleared Hoffmann LRF (Limb Reconstruction Frame) System, in K130907. The additional components of this submission will consist of the following: constrained hinge strut,
5
universal hinge strut, motor struts, spherical washer, hinge bolt, self-locking nut, half hinge, universal joint, adjustment instrument, slotted plate and buckle.
This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II, Hoffman II MRI and Hoffmann 3 External Fixation System, and the Apex Fixation Pins.
Intended Use:
The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
Indications:
The Stryker Hoffmann LRF (Limb Reconstruction Frame) 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 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
The Stryker 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
Summary of Technologies:
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate devices:
- . Hoffmann LRF (Limb Reconstruction Frame) System- K113327/ K130334/ K130907
- . External Fixation System (Smith and Nephew)- K031181
Non-Clinical Testing:
Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the additional components and component compatibility. Testing was
6
performed with compliance to ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device." Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System added components are substantially equivalent to the predicate device components. Testing included the following:
- Static Cantilever Bending Test ●
- Dynamic Cantilever Bending Test
- . Dynamic Frame Testing
Clinical Testing: Clinical testing was not required for this submission.
Conclusion: The Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to the predicate devices identified in this premarket notification.