(140 days)
No
The device description and performance studies focus on mechanical components and structural integrity, with no mention of AI/ML or related concepts.
Yes.
The device is described as an external fixation device used for the treatment and fixation of various musculoskeletal conditions such as fractures, joint contractures, limb lengthening, and deformity correction, which falls under the definition of a therapeutic device.
No
The device is an external fixation system used for the treatment and fixation of fractures, deformities, and other bone-related issues, not for diagnosing them.
No
The device description explicitly lists numerous hardware components (rings, rods, struts, bolts, etc.) and describes it as an "external fixation device." There is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the physical fixation and manipulation of bones and soft tissues in the body (fractures, fusions, lengthening, deformity correction, etc.). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device description details components of an external fixation system (rings, rods, struts, wires, pins). These are mechanical components used to stabilize and manipulate anatomical structures.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the body (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the device (static and dynamic frame testing, wire strength, etc.), which are relevant to its intended physical function. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Hoffmann LRF System does not fit this definition.
N/A
Intended Use / Indications for 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.
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
Product codes
KTT
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Hoffmann LRF (Limb Reconstruction Frame) System. 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 bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.
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, 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 laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System components to determine substantial equivalence. Non-clinical testing was performed with compliance to ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device." Static and dynamic frame testing was performed. Wire Strength, Compression, Bending, Slipping and Splitting testing was also performed on the frame components. Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to devices currently cleared for marketing.
Key Metrics
Not Found
Predicate Device(s)
K031181 External Fixation Systems (Smith & Nephew)
Reference Device(s)
K041706 Hoffman II Foot Ring, K003018 Titan Tibial Nail (T2 Nail)
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.
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11327
Page 1/2
MAR 2 9 2012
| 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: | 87 KTT-Appliance, fixation, nail/blade/plate combination, |
| multiple component | |
| For Information contact: | Estela Celi, Regulatory Affairs Associate |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6461 Fax: (201) 831-3461 | |
| Date Prepared: | November 8, 2011 |
510(k) Summary of Safety and Effectiveness
Description:
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Hoffmann LRF (Limb Reconstruction Frame) System. 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 bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.
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.
1
Page 2/2
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:
- K031181 External Fixation Systems (Smith & Nephew) �
- K041706 Hoffman II Foot Ring
- . K003018 Titan Tibial Nail (T2 Nail)
Non-Clinical Testing:
Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System components to determine substantial equivalence. Non-clinical testing was performed with compliance to ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device." Static and dynamic frame testing was performed. Wire Strength, Compression, Bending, Slipping and Splitting testing was also performed on the frame components. Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to devices currently cleared for marketing.
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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head turned to the side.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
Received: March 16, 2012
MAR 2 9 2012
Re: K113327
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: March 15, 2012
Dear Ms. Celi:
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
3
Page 2 - Ms. Estela Celi
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K11332.7
Indications for Use
510(k) Number (if known): K113327
Device Name: Hoffmann LRF (Limb Reconstruction Frame) System
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 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 t
- Charcot foot reconstruction ●
- Lisfranc dislocations
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) . (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dall
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113327