(214 days)
Synthes Ti Alloy HTO System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component.
Synthes Ti Alloy HTO System is an instrument and implant system. It 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 of the 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 holes in the plate. A standard 4.5 mm cortex screw and 5.0 mm locking screw are available for use with the plates.
This document is a 510(k) summary for a medical device (HTO System) and, as such, does not contain the kind of detailed study information (like acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be found in a clinical trial report or a performance study.
The document states: "Based on the results of confidential testing, it is our opinion that the Ti Alloy HTO System is substantially equivalent to Howmedica's Alta Metaphyseal L-Plate." This indicates that the regulatory submission relies on comparison to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics for the new device as a standalone product.
Therefore, I cannot provide the requested information. The document does not describe acceptance criteria for device performance or a study proving it meets those criteria in the way a clinical study report would.
The information provided is primarily:
- Device Description: What the Synthes Ti Alloy HTO System is and its intended use.
- Comparison to a Predicate Device: It states the device is compared to "Howmedica's Alta Metaphyseal L-Plate and 3.7 mm Cortex Screws and 4.2 mm Cancellous Screws."
- Brief Surgical Insertion Steps: A high-level overview of how the device is implanted.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. The logo and the word are closely aligned, creating a unified brand image. The registered trademark symbol is located to the right of the word.
MAR 2 5 1997
Attachment VIII:
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli. PA 19301
Contact: Angela Silvestri (610) 647-9700 August 1996
Synthes Ti Alloy 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 Ti Alloy HTO System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component. It 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 of the 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 holes in the plate. A standard 4.5 mm cortex screw and 5.0 mm locking screw are 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 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 HTO screw) and to the insertion guide. The insertion guide is still attached to the plate which is secured to the provimal 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 nost proximal posterior hole to achieve interfragmental compression across the osteotomy site.
Based on the results of confidential testing, it is our opinion that the Ti Alloy HTO System is substantially equivalent to Howmedica's Alta Metaphyseal L-Plate.
§ 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.