Who is the manufacturer of FOREFOOT RECONSTRUCTION SYSTEM?

Howmedica Corp. filed the 510(k) submission for FOREFOOT RECONSTRUCTION SYSTEM (K961485).

What is the FDA product code for FOREFOOT RECONSTRUCTION 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 FOREFOOT RECONSTRUCTION SYSTEM?

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

Who can help prepare an FDA 510(k) submission like FOREFOOT RECONSTRUCTION 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.

FOREFOOT RECONSTRUCTION SYSTEM

Q: What are the predicate devices for FOREFOOT RECONSTRUCTION SYSTEM?

Luhr® Fixation System (Howmedica Inc.); Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.); Synthes® Small Fragment and Mini Set (Synthes USA).

K961485 · Howmedica Corp. · HRS · Jun 1, 1996 · Orthopedic

Device Facts

Record ID	K961485
Device Name	FOREFOOT RECONSTRUCTION SYSTEM
Applicant	Howmedica Corp.
Product Code	HRS · Orthopedic
Decision Date	Jun 1, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The system is intended for use in internal fixation of small bones including the foot, hand, craniofacial skeleton and midface.

Device Story

Forefoot Reconstruction System; series of Ti6Al4V titanium alloy screws; diameters 2.3-3.0 mm; lengths 8-22 mm; fully threaded; self-tapping; internal hex-drive heads. Used for internal fixation of small bones in foot, hand, craniofacial skeleton, and midface. Operated by surgeons in clinical/OR settings to stabilize bone fractures or osteotomies. Provides mechanical fixation to facilitate bone healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Ti6Al4V titanium alloy. Design: Fully threaded, self-tapping screws with internal hex-drive heads. Dimensions: 2.3-3.0 mm diameter, 8-22 mm length. Mechanical fixation device.

Indications for Use

Indicated for internal fixation of small bones in the foot, hand, craniofacial skeleton, and midface.

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

Luhr® Fixation System (Howmedica Inc.)
Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.)
Synthes® Small Fragment and Mini Set (Synthes USA)

Related Devices

K963739 — LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS · Howmedica Leibinger, Inc. · Jan 22, 1997
K170889 — HV Screw System · Wrightmedicaltechnologyinc · Apr 26, 2017
K961498 — RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.) · Howmedica, Inc. · Feb 6, 1997
K081510 — TIGER CANNULATED SCREW SYSTEM · Trilliant Surgical, Ltd. · Aug 4, 2008
K120390 — SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET · Solana Surgical, LLC · Apr 10, 2012

Submission Summary (Full Text)

{0} JUL _ 1 1986 510(k) SUMMARY R96148S # Device: Forefoot Reconstruction System Proprietary Name: Forefoot Reconstruction System Common Name: Small Bone Screw System Classification Name and Reference: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 888.3030 Proposed Regulatory Class: Class II Device Product Code: 87HRS 763EY For information contact: John Dichiara Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201)-507-7386 Fax: (201)-507-6870 The Forefoot Reconstruction System is a series of Ti6Al4V titanium alloy screws 2.3-3.0 mm in diameter and 8-22 mm in length. The system is intended for use in internal fixation of small bones including the foot, hand, craniofacial skeleton and midface. All screws are fully threaded and self-tapping with internal hex-drive heads. The substantial equivalence of these devices is based on equivalence in intended use, design, materials and operating principles to several legally marketed devices including the Luhr® Fixation System (Howmedica Inc.), the Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.) and the Synthes® Small Fragment and Mini Set (Synthes USA).