BIOSCREW ABSORBABLE INTERFERENCE SREW

K973758 · Linvatec Corp. · HWC · Feb 27, 1998 · Orthopedic

Device Facts

• Record ID: K973758
• Device Name: BIOSCREW ABSORBABLE INTERFERENCE SREW
• Applicant: Linvatec Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioScrew is used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction. The BioScrew is used to provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis). The BioScrew is used to provide interference fixation during posterior cruciate ligament reconstruction. Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.

Device Story

BioScrew is a cannulated, sterile, single-use bone screw for orthopedic ligament reconstruction. Fabricated from absorbable Poly (L-lactic Acid) homopolymer; designed to gradually absorb into the body post-implantation. Used by orthopedic surgeons during arthroscopic or arthrotomy procedures to provide interference fixation for bone-tendon-bone or soft tissue grafts in ACL and PCL reconstructions. Device acts as a mechanical fastener to secure grafts within bone tunnels. Benefits include elimination of need for secondary hardware removal due to bioabsorbable material properties.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons, with planned bench testing for strength and degradation.

Technological Characteristics

Cannulated, headless, rounded-head bone screw. Material: Poly (L-lactic Acid) homopolymer. Dimensions: 7mm-11mm diameter, 20mm-30mm length. Sterilization: Ethylene Oxide. Shelf life: 24 months. Single-use. Mechanical fixation principle.

Indications for Use

Indicated for patients undergoing anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstruction requiring interference fixation of patellar bone-tendon-bone grafts or soft tissue grafts (semitendinosus, gracilis).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Linvatec BioScrew Absorbable Interference Screw (K960652, K960940)
• Arthrex Non-sheathed Interference Screws (K915424)
• Arthrotek Interference Screw (K934469)

Submission Summary (Full Text)

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11311 Concept Boulevard - Largo, Florida - 3773 - 813 399-5334 - Fax [phone]

# Carol A. Weideman, Ph.D.

Director Regulatory Affairs

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October 1, 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

# BioScrew® Absorbable Interference Screw

In accordance with the requirements of the Safe Medical In accordance #1ch and 21 CFR 807.92, Linvatec Corporation Device Hot of itting the 510(k) Summary of Safety and Absorbable Interference Effectiveness for the BioScrew® Screw.

## Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

# Company Contact B.

Carol A. Weideman, Ph.D. Director, Regulatory Affairs

## Device Name C.

BioScrew® Absorbable Interference Screw Trade Name : Bone Screw Common Name: Smooth or threaded metallic bone Classification Name: fixation fastener

# Predicate/Legally Marketed Devices D.

Linvatec BioScrew Absorbable Interference Screw Arthrex Interference Screws Arthrotek Interference Screw

# Device Description E .

The BioScrew Absorbable Interference Screw is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-lactic Acid) similar to that used in bioabsorbable suture and will gradually be absorbed into the body.

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Summary of Safety and Effectiveness BioScrew® Absorbable Interference Screw 510 (k) # _ K973758 October 1, 1997 Page 2 of 3

### Intended Use F.

- The BioScrew is used to provide interference 1. fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
- The BioScrew is used to provide interference 2. fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
- The BioScrew is used to provide interference 3. fixation during posterior cruciate ligament reconstruction.

Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.

### Substantial Equivalence G.

The BioScrew Absorbable Interference Screw is substantially equivalent in design, function and intended use to Linvatec BioScrew Absorbable Interference Screw, Arthrex Interference Screws and Arthrotek Interference Screws.

Strength and degradation tests are planned to compare the BioScrew to the Arthrex and/or BioMet screws.

The similarities/dissimilarities to the predicate are shown in the attached table.

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# CHART OF SIMILARITIES AND DISSIMILARITIES

(

| Company Name | Device Name | Intended Use | Material | Single-Use<br>Reusable | Method of<br>Sterilization | Design |
|-------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------|---------------------------------------------|---------------------------------------------------------------------------------------|
| New Product<br>Invatec | BioScrew®<br>Absorbable<br>Interference<br>Screw | Provide interference fixation:<br>1. Patellar bone-tendon-bone<br>grafts in ACL reconstruction<br>2. Femoral and/or tibial<br>fixation in ACL<br>reconstruction using a soft<br>tissue graft<br>3. PCL reconstruction | Poly<br>(L-lactic Acid) | Sterile<br>Single-use | Ethylene<br>Oxide<br>24 month<br>shelf life | Cannulated<br>Headless & rounded<br>head<br>Diameter: 7mm-11mm<br>Length: 20mm-30mm |
| Predicate<br>Invatec | BioScrew®<br>Absorbable<br>Interference<br>Screw<br>510(k) #K960652<br>#K960940 | Provide interference fixation:<br>1. Patellar bone-tendon-bone<br>grafts in ACL reconstruction<br>2. Femoral and/or tibial<br>fixation in ACL<br>reconstruction using a soft<br>tissue graft<br>3. PCL reconstruction | Poly<br>(L-lactic Acid) | Sterile<br>Single-use | Ethylene<br>Oxide<br>24 month<br>shelf life | Cannulated<br>Headless and rounded<br>head<br>Diameter: 7mm-9mm<br>Length: 20mm-30mm |
| Predicate<br>Arthrex,<br>Inc. | Non-sheathed<br>Interference<br>Screws<br>Full Threaded<br>Screws<br>510(k) #K915424 | Tibial ACL fixation, PCL<br>femoral and tibial fixation and<br>standard two incision type ACL<br>procedures | Titanium | Sterile<br>Single-use | Unknown | Cannulated<br>Headless and rounded<br>head<br>Diameter: 6mm-10mm<br>Length: 20mm-30mm |
| Predicate<br>BioMet,<br>Inc. | Arthrotek<br>Interference<br>Screw<br>510(k) #K934469 | Interference fixation ACL and<br>PCL reconstruction | Titanium | Sterile or<br>non-sterile<br>Single-use | Unknown | Rounded head<br>Diameter: 7mm-10mm<br>Length: 20mm-30mm |

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB < 7 1998

Carol A. Weideman, Ph.D. Director, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

Re: K973758 BioScrew® Absorbable interference Screw Regulatory Class: II Product Codes: HWC and MAI Dated: January 19, 1998 Received: January 20, 1998

Dear Dr. Weideman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further, announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Carol A. Weideman, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

**Sincerely yours,**

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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LINVATEC/HALL SUSGICAL PHOPRIETARY INFORMATION

This information is exempt from

disclosure under Exemptions 3 and 4 11311 Concept Boulevard Largo, Florida 737734908 8139264665 11:5 Freedom of Information Act

October 1, 1997 Date:

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510(k) Number (if known): K973758

BioScrew® Absorbable Interference Screw Device Name:

Indications for Use:

- The BioScrew is used to provide interference fixation 1. of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
- The BioScrew is used to provide interference fixation 2. during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
- The BioScrew is used to provide interference fixation 3. during posterior cruciate ligament reconstruction.

Implantation of the interference screw is accomplished This device is a singlethrough arthroscopy or arthrotomy. use device.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED }

Concurrence of CDRH, Office of Device Evaluation (ODB)

Prescription Use *\\$\times\$_
OR
Over-the-Counter Use* _

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number *k973758*(Optional Format 1-2-96)

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A Bristol-Myers Squibb Company