BIOLOK SCREW, BIOSTEON SCREW

K003641 · Biocomposites, Ltd. · HWC · Feb 8, 2001 · Orthopedic

Device Facts

• Record ID: K003641
• Device Name: BIOLOK SCREW, BIOSTEON SCREW
• Applicant: Biocomposites, Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Feb 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon: - places the graft in tibial and/or femoral tunnels; and - inserts screws between the tunnel wall and graft to hold the graft in place. The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction. The Biosteon™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

Device Story

Biosteon™ Screw is a cannulated, sterile, single-use bone fixation screw; composed of hydroxyapatite (HA) and poly (L-lactide) (PLLA) absorbable polymer. Used by orthopedic surgeons in ACL reconstruction procedures; device inserted between tunnel wall and graft to provide interference fixation for patellar bone-tendon-bone or soft tissue grafts. Material gradually absorbs into body. Provides mechanical graft stability during healing. Device is a passive implant; no electronic or software components.

Clinical Evidence

Bench testing only. Pull-out test results demonstrate strength comparable to predicate devices, confirming the composite material provides early and sustained graft fixation.

Technological Characteristics

Cannulated bone screw; material: composite of Hydroxyapatite (HA) and poly (L-lactide) (PLLA) absorbable polymer. Sterile, single-use. Passive mechanical fixation device.

Indications for Use

Indicated for patients undergoing anterior cruciate ligament (ACL) reconstruction requiring interference fixation of patellar bone-tendon-bone grafts or soft tissue grafts (semi-tendonosis gracilis) in tibial and/or femoral tunnels.

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

• Bio Interference Screw (Arthrex)
• BioScrew (Livatec)
• BioLok® Screw (Biocomposites)

Submission Summary (Full Text)

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### 510(K) Summary of Safety and Effectiveness

FEB = 8 2001

K003641/

- (1) Submitter's name: Submitter's address:
Submitter's telephone number: Contact person: Date summary prepared:

- (2) Trade or proprietary device name: Common or usual name: Classification name:
Legally marketed predicate device:

Biocomposites Ltd Etruscan Street, Etruria, Stoke-on-Trent, ST1 5PQ, England 44 (0) 1782 206500 Stephen Bratt 22 November 2000

Biosteon™ Screw Bone Fixation Screw Class II

Bio Interference Screw (Arthrex) BioScrew (Livatec) BioLok® Screw (Biocomposites)

#### (4) Subject device description:

(3)

The Biosteon™ Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The Biosteon™ Screw is manufactured from a mixture of Hydroxyapatite (HA) and poly (L-lactide) (PLLA).

#### (5) Subject device intended use:

The Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:

- · places the graft in tibial and/or femoral tunnels; and
- · inserts screws between the tunnel wall and graft to hold the graft in place.

The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.

The Biosteon™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

#### (6) Technological characteristics:

The Biosteon™ Screw has the same technological characteristics (i.e., design and material) when compared to the predicate devices.

### (7) Performance data:

Test results confirm that this composite has the requisite strength to provide early and sustained fixation of the graft. Pull out test results compare favourably with the predicate devices.

### (8) Basis for substantial equivalence:

The Biosteon™ Screw is equivalent in design, materials and indications to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like design with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

FEB - 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. J. Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Etruria Stoke-on-Trent Staffordshire, ST1 5PQ United Kingdom

Re: K003641

Trade Name: Biosteon™ Screw Regulatory Class: II Product Code: HWC Dated: November 22, 2000 Received: November 27, 2000

Dear Mr. Bratt:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave 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 stated in the enorouse) to certice Amendments, or to devices that have been reclassified in enacinent ante of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provident to the general control provisions of the Act. The general therefore, market 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 ( Fenance . Ipple any 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspootions, the Food and may result in regulatory action. In addition, FDA may publish compy was and One over ing 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 - Mr. J. Stephen Bratt

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the officing additionally 809.10 for in Villo diagnostic ac nows, promotion and advertising of your device, and device, and [phone]. Additionally, for questions on the presente the regulation please contact the Office of Comphance at (301) 977 Vestion" (21 CFR 807.97). Other general entitled, "Misbranding by telefice under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained from the 100 m information on your responsibilities under in Archile, 68 code 1 or [phone] or at its
Manufacturers Assistance at its toll-free number [phone] or [phone] Manufacturers "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

L. Mark N. Mulkerson

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

Enclosure

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K003641

## Biosteon™ Screw

## Indications For Use

The Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:

- places the graft in tibial and/or femoral tunnels; and .
- · inserts screws between the tunnel wall and graft to hold the graft in place.

The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.

The Biosteon™ Screw is used to provide interference fixation during femoral and/or The Diostcon in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

L. Mark N. Millman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K003641