(145 days)
Howmedica's Alta Metaphyseal L-Plate
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No
The description focuses solely on the mechanical components and intended use of a surgical implant system, with no mention of AI or ML technologies.
Yes
The device is described as an "instrument and implant system intended for high tibial osteotomies to correct leg malaignments causing unicompartmental osteoarthritis," indicating its use in treating a medical condition.
No
The device description indicates it is an instrument and implant system for surgical correction of leg misalignments. It is an osteotomy system, not a diagnostic tool.
No
The device description explicitly details physical components like plates, screws, and their dimensions, indicating it is a hardware-based system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "instrument and implant system intended for high tibial osteotomies to correct leg malaignments causing unicompartmental osteoarthritis." This describes a surgical device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details plates, screws, and their locking mechanisms, all components of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
This device is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Synthes HTO System is an instrument and implant system intended for high tibial osteotomies to correct leg malaignments causing unicompartmental osteoarthritis.
Product codes
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Device Description
The HTO System utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation.
The plates are available with an anatomically contoured head. The 5.0 mm locking screw has a round cross section with a threaded conical underside to fit into the plate. The underside has a tapered thread to match the design of the plate. The locking screw is available in lengths ranging between 26 and 65 mm. Standard 4.5 mm cortex screws (lengths 80 - 100 mm) and 4.5 mm shaft screws (lengths 80 - 100 mm) are also available for use with the plates.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tibia
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
confidential testing
Key Metrics
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Predicate Device(s)
Howmedica's Alta Metaphyseal L-Plate
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 shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person inside of a circle. The logo and the word are the only elements in the image.
DEC 1 7 1996
Attachment D: Summary of Safety and Effectiveness
Synthes (USA) 1690 Russell Road Paoli, PA 19301
Contact: Angela Silvestri
(610) 647-9700
Synthes High Tibial Osteotomy (HTO) System is compared to Howmedica's Alta Metaphyseal L-Plate and 3.7 mm Cortex Screws and 4.2 mm Cancellous Screws
Synthes HTO System is an instrument and implant system intended for high tibial osteotomies to correct leg malaignments causing unicompartmental osteoarthritis. The HTO System utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation.
The plates are available with an anatomically contoured head. The 5.0 mm locking screw has a round cross section with a threaded conical underside to fit into the plate. The underside has a tapered thread to match the design of the plate. The locking screw is available in lengths ranging between 26 and 65 mm. Standard 4.5 mm cortex screws (lengths 80 - 100 mm) and 4.5 mm shaft screws (lengths 80 - 100 mm) are also available for use with the plates.
The following briefly describes the insertion of this device:
- a) The Linear Saw Guide is positioned over two K-wires which have been anatomically located. The depth of the bone is measured through the guide and the desired cutting depth is set. The oscillating saw blade is inserted through the guide and cuts are made at the desired angles. The Linear Saw Guide and K-wires are then removed.
- b) The insertion guide is attached to the HTO System plate via a threaded hole in the plate. The attachment of an insertion guide will facilitate the coaxial alignment of the screw and plate during screw insertion.
- c) The plate is inserted after the osteotomy is performed. The most distal end of the plate will be inserted first. This end features a tapered rounded section, which will serve to gently lift up and separate tissue allowing the plate, via the insertion guide, to be manipulated to the bone surface. This insertion process will reduce soft tissue stripping.
- d) An insertion sleeve will then be insertion guide. The sleeve facilitates the alignment of the screw driver, the screw and the plate.
- e) Once in place, bridging the osteotomy, the most proximal anterior screw will be inserted first.
- f) The closing forceps are then attached to the distal fragment (via HT() screw) and to the insertion guide. The insertion guide is still attached to the plate which is secured to the proximal fragment. The instrument is slowly manipulated to bring the distal fragment into proper alignment.
- g) Upon achieving proper alignment the remaining screws are inserted.
- h) A standard 4.5 mm cortex screw is inserted into the most proximal posterior hole to achieve interfragmental compression across the osteotomy site.
Based on the results of confidential testing, it is our opinion that the HTO System is substantially equivalent to Howmedica's Alta Metaphyseal L-Plate.