ACUMED BONE GRAFT SYSTEM

K960711 · Acu Med, Inc. · KIJ · May 7, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960711
• Device Name: ACUMED BONE GRAFT SYSTEM
• Applicant: Acu Med, Inc.
• Product Code: KIJ · General, Plastic Surgery
• Decision Date: May 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.

Device Story

System comprises drills, Hudson adaptor, starting punch, bone plug extractor, and removal key; designed for bone harvesting. Hudson adaptor connects to standard DC-powered surgical drill; starting punch creates reference dimple; drill harvests bone; removal key detaches drill; plug extractor removes bone material. Used in surgical settings by clinicians. Benefits include standardized bone harvesting process.

Clinical Evidence

Bench testing only; validation of steam sterilization process parameters to achieve SAL of 10^-6.

Technological Characteristics

Manufactured from 17-4 PH stainless steel. Manual and DC-powered drill operation. Non-sterile, steam sterilizable.

Indications for Use

Indicated for use in bone grafting procedures to harvest bone material.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Wright Medical Technology’s Precision Bone Grafting System

Submission Summary (Full Text)

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ACUMED™

Quality Orthopaedic Instruments and Implants

# Enclosure D - 510(k) Summary

**K 960711** MAY - 7 1996

This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.

The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.

The Acumed Bone Graft System is manufactured from 17-4 ph stainless steel. The instruments are provided non-sterile. Data that validates a set of recommended steam sterilization process parameters which obtain a resulting SAL of $10^{-6}$ are maintained on file at Acumed. Information regarding implantation, packaging, and labeling have been provided.

The Acumed Bone Graft System is similar to Wright Medical Technology’s Precision Bone Grafting System in form, function, composition, and indications and is expected to perform as well as similar devices.

10950 SW 5th St., Suite 170 • Beaverton, OR 97005 • [phone] • Fax: [phone] • Form # FBGI-05 02/15/96 Page 8 of 9 © 1995, Acumed, Inc.