Who is the manufacturer of OMEGA+ COMPRESSION SCREW SYSTEM?

Howmedica Corp. filed the 510(k) submission for OMEGA+ COMPRESSION SCREW SYSTEM (K955306).

What is the FDA product code for OMEGA+ COMPRESSION SCREW SYSTEM?

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

What is the regulatory pathway for OMEGA+ COMPRESSION SCREW SYSTEM?

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

What are the predicate devices for OMEGA+ COMPRESSION SCREW SYSTEM?

K850886; K872223; K922295; K930156.

Who can help prepare an FDA 510(k) submission like OMEGA+ COMPRESSION SCREW 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.

OMEGA+ COMPRESSION SCREW SYSTEM

K955306 · Howmedica Corp. · KTT · Apr 10, 1996 · Orthopedic

Device Facts

Record ID	K955306
Device Name	OMEGA+ COMPRESSION SCREW SYSTEM
Applicant	Howmedica Corp.
Product Code	KTT · Orthopedic
Decision Date	Apr 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area).

Device Story

Metallic bone fixation system; includes lag screws, proximal hip sideplates, supracondylar side plates, and compression screw. Used for temporary stabilization of proximal and distal femoral fractures. Components previously cleared; current submission introduces sterile packaging option. Intended for use by orthopedic surgeons in clinical/surgical settings. No changes to design, materials, manufacturing, or surgical technique.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established via comparison to previously cleared predicate devices.

Technological Characteristics

Metallic bone fixation appliances; components include lag screws, sideplates, and compression screws. No changes to materials or design from predicate devices. Sterilization provided via validated technique for sterile packaging option.

Indications for Use

Indicated for temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric) and/or distal third of the femur (supracondylar area).

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

Related Devices

K982553 — OSTEO COMPRESSION HIP SCREW SYSTEM · Osteonics Corp. · Sep 22, 1998
K150456 — Arthrex Plates, Screws, and Staples · Arthrex, Inc. · Apr 29, 2015
K241262 — Baby Gorilla/Gorilla Plating System; Monster Screw System · Paragon 28, Inc. · Jun 5, 2024
K190321 — Pediatric Nailing PlatformFemur · OrthoPediatrics Corp. · Oct 9, 2019
K193543 — CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System · In2bones USA, LLC · Jan 17, 2020

Submission Summary (Full Text)

{0} K955306 510(k) Summary of Safety and Effectiveness Proprietary Name: Omega+ Compression Screw System Common Name: Compression Screw System Classification Name and Reference: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories Proposed Regulatory Class: Class II Device Product Code: KTT OR(87) For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica 359 Veterans Boulevard Rutherford, New Jersey 07070 Telephone: (201) 507-7431 Fax: (201) 507-6870 Date Summary Prepared: 11-9-95 The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made available in sterile packaging. It is Howmedica's intention to market these products both sterile and non-sterile. Directions for one recommended sterilization technique are included in the labeling for the device. There is no change in intended use, design, material, method of manufacture, or surgical technique for the device.