Who is the manufacturer of SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM?

Synthes (Usa) submitted the Traditional clearance for SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM (K962894).

What is the FDA product code for SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM?

510(k) clearance (submission type: Traditional).

SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM

K962894 · Synthes (Usa) · HRS · Dec 17, 1996 · Orthopedic

Device Facts

Record ID	K962894
Device Name	SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
Applicant	Synthes (Usa)
Product Code	HRS · Orthopedic
Decision Date	Dec 17, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Synthes High Tibial Osteotomy (HTO) System is an instrument and implant system intended for high tibial osteotomies to correct leg malalignments causing unicompartmental osteoarthritis.

Device Story

System comprises plates, locking screws, and surgical instruments for high tibial osteotomy; corrects leg malalignment causing unicompartmental osteoarthritis. Procedure: Linear Saw Guide positioned via K-wires to guide oscillating saw for bone cuts; plate inserted via insertion guide to minimize soft tissue stripping; locking screws secure plate to bone via unicortical or bicortical fixation; closing forceps manipulate distal fragment into alignment; standard cortex screw provides interfragmental compression. Used in orthopedic surgery by physicians. Benefits: stable fixation, anatomical contouring, reduced soft tissue trauma.

Clinical Evidence

No clinical data provided; substantial equivalence based on confidential bench testing.

Technological Characteristics

System includes anatomically contoured plates and 5.0 mm locking screws with threaded conical undersides. Features insertion guides and sleeves for coaxial alignment. Locking mechanism secures screw to plate. Compatible with standard 4.5 mm cortex and shaft screws. Mechanical fixation device.

Indications for Use

Indicated for patients requiring high tibial osteotomy to correct leg malalignments resulting in unicompartmental osteoarthritis.

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

Related Devices

K963325 — SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM · Synthes (Usa) · Mar 25, 1997
K041601 — SURFIX KNEE OSTEOTOMY SYSTEM · Surfix Technologies · Aug 27, 2004
K100604 — OTIS -C PLUS · Sciences ET Bio Materiaux (Sbm) · Jun 14, 2010
K212545 — FlexitSystem Knee osteotomy system · Neosteo · Feb 11, 2022
K120818 — OTIS-C PLUS · Science For Biomaterials · Apr 19, 2012

Submission Summary (Full Text)

{0} SYNTHES K962894 DEC 17 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 malalignments 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 head of 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 holes in 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 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 HTO System is substantially equivalent to Howmedica's Alta Metaphyseal L-Plate.