PINN-ACL CROSSPIN

K043106 · Linvatec Corp. · HTY · Jan 19, 2005 · Orthopedic

Device Facts

• Record ID: K043106
• Device Name: PINN-ACL CROSSPIN
• Applicant: Linvatec Corp.
• Product Code: HTY · Orthopedic
• Decision Date: Jan 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pinn–ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.

Device Story

Pinn-ACL® CrossPin system comprises absorbable crosspin and graft harness implants; used for femoral fixation of soft tissue grafts during knee cruciate ligament reconstruction. Implants manufactured from poly L-lactic acid; used with manual, reusable instruments to facilitate precise implant positioning. Implants are single-use and sterile; instruments are non-sterile and require sterilization before use. System utilized by surgeons in clinical/OR settings to secure grafts during ligament repair. Output is mechanical fixation of graft to bone; aids in stabilizing knee joint post-reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Implants composed of poly L-lactic acid (absorbable) and high-strength polyethylene fiber. System includes manual, reusable instruments. Single-use sterile implants; reusable instruments require sterilization. Mechanical fixation principle.

Indications for Use

Indicated for femoral fixation of soft tissue grafts during knee cruciate ligament reconstruction.

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-Transfix (K011172)
• Rigid Fix® (K974341)
• Bionx SmartScrew® (K003077)
• BioScrew® (K973758)

Submission Summary (Full Text)

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K04-3106 pg143

# JAN 1 9 2005

# PROPRIETARY INFORMATION - LINVATEC CORPORATION

November 5, 2004

# SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the Traditional 510(k) Summary of Safety and Effectiveness for the Pinn -ACL CrossPin 510(k) Number _______________________________________________________________________________________________________________________________________________________

### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

### B. Company Contact

Elizabeth M. Paul Manager, Regulatory Affairs [phone] Telephone [phone] FAX

### C. Device Name

Pinn-ACL® CrossPin Trade Name:

Common Name: crosspin

Biodegradable, Soft Classification Names: Fastener, Fixation, Tissue, 21 CFR 888.3030

Proposed Class/Device: Class II

MAI Product Code:

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Summary of Safety and Effectiveness Pinn-ACL® Crosspin 510(k) # November 5, 2004

## Predicate/Legally Marketed Devices D.

| Bio - Transfix<br>Arthrex, Inc. | 510(k) # K011172 |
|-----------------------------------|------------------|
| Rigid Fix®<br>Mitek | 510(k) # K974341 |
| Bionx SmartScrew ®<br>Bionx | 510 (k) # 003077 |
| BioScrew®<br>Linvatec Corporation | 510(k) # K973758 |

### Device Description E.

consists of absorbable crosspin and graft The Linvatec Pinn-ACL® CrossPin harness implants made from poly L-lactic acid, high strength polyethylene fiber to be used with manual, re-useable instruments to facilitate the precise positioning of the implants (Crosspin refers to the both the crosspin and graft harness implants. The implants are single-use and sterile. The instruments are supplied non-sterile and must be sterilized prior to use.

#### F. Intended Use

The Pinn–ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.

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# PROPRIETARY INFORMATION - LINVATEC CORPORATION

## Substantial Equivalence G.

The Pinn-ACL® CrossPin is substantially equivalent to in design and intended use and materials to the Bio – Transfix (510(k) # K011172) and Arthrex, Inc., RigidFix™ (510(k) # K974341).

The Pinn-ACL® CrossPin implant is identical to the materials in the SmartScrew® (510(k) # K003077) and the BioScrew @(510(k) # K097358).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three horizontal lines that curve upwards, resembling a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2005

Ms. Elizabeth M. Paul Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

Re: K043106

Trade/Device Name: Pinn-ACL® CrossPin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: November 5, 2004 Received: November 9, 2004

Dear Ms. Paul:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Elizabeth M. Paul

This letter will allow you to begin marketing your device as described in your Section 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.

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

Sincerely yours.

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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# PROPRIETARY INFORMATION - LINVATEC CORPORATION

November 5, 2004

510(k) Number (if known):

Device Name: Pinn --ACL® CrossPin

Indications for Use:

The Pinn – ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.

Prescription Use ___X____

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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Concurrence of CD/RH, Office of Device/Evaluation (ODE)

Fence of onseptor Dette

Division Sign-6 Division of General, Restorative, and Neurological Devices

510(k) Number.