SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM

K963325 · Synthes (Usa) · HRS · Mar 25, 1997 · Orthopedic

Device Facts

• Record ID: K963325
• Device Name: SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Ti Alloy High Tibial Osteotomy (HTO) System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component.

Device Story

System comprises titanium alloy plates and screws for high tibial osteotomy; used to correct leg malalignment causing unicompartmental osteoarthritis. Procedure involves positioning linear saw guide over K-wires to perform osteotomy; plate inserted via insertion guide to minimize soft tissue stripping. Locking feature secures screw to plate via tapered threaded interface, enabling stable unicortical or bicortical fixation. Surgeon uses insertion sleeve for coaxial alignment of screw/driver/plate; closing forceps manipulate distal fragment into alignment. Standard 4.5 mm cortex screw provides interfragmental compression. Device used in OR by orthopedic surgeons to stabilize bone fragments post-osteotomy, facilitating healing and correcting alignment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium alloy plates and screws; locking mechanism with tapered threaded screw head and plate hole interface; anatomically contoured plate head; includes linear saw guide, insertion guide, insertion sleeve, and closing forceps; non-sterile (implied, requires sterilization).

Indications for Use

Indicated for patients with leg malalignment causing unicompartmental osteoarthritis requiring correction of the tibial component.

Regulatory Classification

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.

Predicate Devices

• Howmedica’s Alta Metaphyseal L-Plate and 3.7 mm Cortex Screws and 4.2 mm Cancellous Screws

Submission Summary (Full Text)

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SYNTHES

MAR 25 1997

K96 3325

# Attachment VIII:

# Summary of Safety and Effectiveness Information

Synthes (USA)
1690 Russell Road
Paoli, PA 19301

Contact: Angela Silvestri
[phone]
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. The 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 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 inserted into the 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 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 Ti Alloy HTO System is substantially equivalent to Howmedica’s Alta Metaphyseal L-Plate.