Who is the manufacturer of SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM?

Synthes (Usa) filed the 510(k) submission for SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM (K961421).

What is the FDA product code for SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM?

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM?

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

Who can help prepare an FDA 510(k) submission like SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM

K961421 · Synthes (Usa) · JEY · Jun 26, 1996 · Dental

Device Facts

Record ID	K961421
Device Name	SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
Applicant	Synthes (Usa)
Product Code	JEY · Dental
Decision Date	Jun 26, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures.

Device Story

Plate and screw system for mandible trauma and reconstruction; plates attach to bone via self-tapping cortex or locking screws; features internally threaded compression screw holes; instrumentation includes threaded drill guides for drill bit alignment and insert screws to protect threaded holes during plate bending; device provided non-sterile; requires moist heat sterilization per AAMI guidelines; used by surgeons in clinical settings; provides mechanical stabilization of bone segments.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: unspecified metal plate and screw system; dimensions: 2.4 mm system with 2.4 mm - 3.0 mm locking screws; drill guides (1.5 mm - 2.5 mm bores); sterilization: moist heat (steam) per AAMI guidelines; non-sterile delivery.

Indications for Use

Indicated for patients requiring mandible trauma repair or reconstruction procedures.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

Synthes 2.7 mm Reconstruction Plate System

Related Devices

K043297 — MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM · Medicon EG · Feb 23, 2005
K081067 — FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) · Biomet Microfixation, Inc. · May 9, 2008
K032442 — KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II · KLS-Martin L.P. · Oct 29, 2003
K071612 — MODUS TRILOCK 2.0/2.3/2.5 · Medartis AG · Sep 11, 2007
K082335 — SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM · Synthes (Usa) · Nov 10, 2008

Submission Summary (Full Text)

{0} SYNTHES K961421 Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary] SYNTHES (USA) 1690 Russell Road Paoli, PA 19301 JUN 26 1996 (610) 647-9700 Contact: Angela Silvestri April 1996 Device: Synthes 2.4 mm Universal Locking Plate System, as compared to Synthes 2.7 mm Reconstruction Plate System. The Synthes 2.4 mm ULPS is a plate and screw system, that is intended for mandible trauma and reconstruction procedures. The plates attach to bone via self-tapping cortex and/or locking screws, and are available in various shapes and sizes. The plates feature compression screw holes that are internally threaded to accept the 2.4 mm - 3.0 mm locking screws. The following instrumentation is used with the 2.4 mm ULPS: Threaded Drill Guide is used for guiding the drill bit to bone by threading the tip into the plate's screw hole. The bore (inside diameter) of the drill guide is dependent upon the screw size when selected since each screw diameter requires a specific drill diameter. They are available with bores from 1.5 mm to 2.5 mm. 2.4 mm Insert Screw is used by the surgeon while bending the plate to avoid deforming the threaded screw holes. The inserts are screwed into the plate holes prior to bending and removed once the bending operation is complete. Synthes will provide the device non-sterile. Of course, non-sterile devices must be sterilized prior to use; moist heat sterilization is recommended using the Association for the Advancement of Medical Instrumentation (AAMI) guideline "Good Hospital Practice: Steam Sterilization and Sterility Assurance." Based on mechanical test results, we believe that the devices are at least equivalent.