ALIGNMENT INSTRUMENT

K970345 · Richard Wolf Medical Instruments Corp. · HSZ · Apr 29, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970345
• Device Name: ALIGNMENT INSTRUMENT
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HSZ · General, Plastic Surgery
• Decision Date: Apr 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K970345 · Apr 29, 1997	ALIGNMENT INSTRUMENT	Richard Wolf Medical Instruments Corp.	Hospital clinical records/routine intervention logs	Retrospective summary of over 200 routine clinical interventions at Eisenstadt Hospital over three years to demonstrate safety, mechanical reliability, and biocompatibility.	Retrospective clinical experience; Routine clinical interventions; Safety monitoring

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Eisenstadt Hospital clinical experience; Retrospective review of routine clinical interventions; Follow-up/Duration: 3 years; Study Period: 1994-1997 (approximate based on submission date)	Patients undergoing ACL reconstruction using the press-fit technique; Sample Size: >200; Number of Sites: 1	Not applicable for this study	Mechanical performance, biological compatibility, sterilization durability

Indications for Use

The ACL instruments are used for the reconstruction of anterior cruciate ligament with the patellar ligament using the press-fit technique. - The drill alignment device ensures precise drilling of the tibial channel. - The pneumatic drill drives the oscillating hollow drills. - The short hollow drill is used for graft removal from the ligament. - The long hollow drill with ejector is used for removing the tibial bone plug used for filling in the graft-removal defects on the patella and the tibia. - The ejector ensures the correct drilling direction and permits subsequent ejection of the bone for the hollow drill.

Device Story

ACL instruments facilitate patellar ligament graft harvesting and bone plug preparation for ACL reconstruction. System includes drill alignment device, pneumatic drill, and oscillating hollow drills. Drill alignment device ensures precise tibial channel drilling (40-45° angle). Pneumatic drill (5-cell lamellar motor) drives hollow drills at up to 3400 rpm with ±20° oscillation. Hollow drills feature toothed cutting edges and rounded segments to protect ligament tissue; standardized diameters promote press-fit technique and bone healing. Ejector mechanism ensures correct drilling direction and bone plug removal. Used in orthopedic surgery by surgeons; instruments are autoclavable. System enables standardized graft removal and defect filling, potentially improving healing outcomes through optimal bone contact.

Clinical Evidence

No formal clinical trials were performed. Evidence consists of retrospective observational data from Eisenstadt Hospital, where the instruments were used in over 200 routine interventions over a three-year period. No mechanical problems or biological incompatibility reactions were reported during this period. Steam sterilization efficacy was confirmed through routine use.

Technological Characteristics

Instruments include drill alignment guides, pneumatic drill with 5-cell lamellar motor, and oscillating hollow drills. Hollow drills feature toothed cutting edges and rounded segments. System is autoclavable (steam sterilization). Drill alignment provides 40-45° angle control. Pneumatic drill operates at 3400 rpm with ±20° oscillation. No electronic or software components.

Indications for Use

Indicated for patients requiring anterior cruciate ligament (ACL) reconstruction using the patellar ligament press-fit technique.

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

• ACL-Drill Guide Instrument, type 8870.152 (K940125)
• Alignment instrument, type 8731
• Alignment instrument, type AR 1875
• Pneumatic drill, type GA 207
• Coring Reamer, type AR-1223CR

Submission Summary (Full Text)

{0}

Richard Wolf Medical Instruments Corporation
APR 29 1997
1<970345
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

| 510(k) Summary of Safety and Effectiveness | | | | |
| --- | --- | --- | --- | --- |
| Submitter: | | | Date of Preparation: January 24, 1997 | |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | |
| Division name (if applicable): N.A. | | | Phone number (include area code): [phone] | |
| Street address: 353 Corporate Woods Parkway | | | FAX number (include area code): [phone] | |
| City: Vernon Hills | State/Province: Illinois | Country: USA | | ZIP / Postal Code: 60061 |
| Contact name: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: ACL instruments and instrumentation | | Model number: 8869.011 8869.111 8869.151
8869.152 8869.911 8869.841
8869.842 | | |
| Common name: ACL instruments | | Classification name: Endoscope and accessories | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 K940125 | 1 ACL-Drill Guide Instrument, type 8870.152 | | 1 Richard Wolf | |
| 2 | 2 Alignment instrument, type 8731 | | 2 Linvatec | |
| 3 | 3 Alignment instrument, type AR 1875 | | 3 Arthrex | |
| 4 | 4 Pneumatic drill, type GA 207 | | 4 Aésculap | |
| 5 | 5 Coring Reamer, type AR-1223CR | | 5 Arthrex | |
| 6 | 6 | | 6 | |

## 1.0 Description

The ACL instrument by Boszotta allows fast and standardized removal of the patellar ligament by an optimal arthroscopic press-fit technique. The standardized diameter of the bone plugs allows optimum bone contact and promotes rapid healing.

RICHARD WOLF

{1}

Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

## 2.0 Intended Use

The ACL instruments are used for the reconstruction of anterior cruciate ligament with the patellar ligament using the press-fit technique.

- The drill alignment device ensures precise drilling of the tibial channel.
- The pneumatic drill drives the oscillating hollow drills.
- The short hollow drill is used for graft removal from the ligament.
- The long hollow drill with ejector is used for removing the tibial bone plug used for filling in the graft-removal defects on the patella and the tibia.
- The ejector ensures the correct drilling direction and permits subsequent ejection of the bone for the hollow drill.

## 3.0 Technological Characteristics

- The drill alignment device ensures precise drilling of the tibial channel at an angle of 40-45° to the axis of the tibial shaft to achieve sufficient dorsal positioning of the femoral channel. It includes a small standard drill guide for a drilling wire and a large drill guide for a hollow drill.
- The pneumatic drill works has a 5-cell lamellar motor with oscillation head and finger-controlled speed adjustment. It drives hollow drills with oscillation frequency up to 3400 rpm and oscillating motion angle of ±20°.
- The hollow drills consist essentially of an oscillating hollow tube, which rotates about its longitudinal axis. Three quarters of the circumference of the cutting edge of the hollow drill is toothed. The segment of the hollow drill facing the ligament is rounded. The closed shape with a scale on the outer surface standardizes the diameter and the removal depth of the bone plugs.

All ACL instruments are autoclavable (steam sterilization) for high hygiene demands.

## 4.0 Substantial Equivalence

The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf and/or sold by competitors.

## 5.0 Performance Data

The ACL Instruments by Boszotta have been used in Eisenstadt Hospital for accident cases for about three years. During this time the instruments were used in more than 200 routine interventions. At this time, no mechanical problems or biological incompatibility reactions have been reported. The steam sterilization following each operation do not show any problems.

## 6.0 Clinical Tests

No clinical tests performed.

RICHARD WOLF

{2}

Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

## 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.

By: Robert L. Casarsa
Quality Assurance Manager
Date: Jan 24, 97

RICHARD WOLF