BIO-MINI REVO SUTURE ANCHOR

K053561 · Conmed Linvatec · HWC · Feb 23, 2006 · Orthopedic

Device Facts

• Record ID: K053561
• Device Name: BIO-MINI REVO SUTURE ANCHOR
• Applicant: Conmed Linvatec
• Product Code: HWC · Orthopedic
• Decision Date: Feb 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bio-Mini Revo Suture Anchor ™ is intended for use in arthroscopic or open surgical procedures to reattach soft tissues to the bone.

Device Story

Bio-Mini Revo Suture Anchor is a bioabsorbable screw-in fastener; preloaded on disposable inserter with one non-absorbable, braided, ultrahigh molecular weight polyethylene suture. Used in arthroscopic or open surgical procedures by surgeons to reattach soft tissues (ligaments, tendons, joint capsules) to bone. Anchor provides secure fixation during healing period. Device available with or without D&C violet #2 colorant.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bioabsorbable screw-in suture anchor; material: Self-Reinforced (96/4D) PLA Copolymer; includes non-absorbable, braided, ultrahigh molecular weight polyethylene suture; disposable inserter; optional D&C violet #2 colorant.

Indications for Use

Indicated for reattachment of soft tissue, such as ligaments, tendons, or joint capsules, to bone in arthroscopic or open surgical procedures.

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

• Duet Suture Anchor (K020056, K042966)
• Impact Suture Anchor (K030388, K042966)
• BioScrew XtraLok (K050497)
• BioStinger Hornet (K020377)
• BioStinger -V Bioabsorbable Meniscal Repair Device (K991715)

Submission Summary (Full Text)

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page 1 of 3

## FEB 2 3 2006

December 16, 2005

## 510(k) Submission

## 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 a 510(k) Summary of Safety and Effectiveness for the Bio-Mini Revo Suture Anchor.

510(k) # 053556/

#### Submitter A.

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

#### Company Contact B.

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

#### C. Device Name

Bio-Mini Revo Suture Anchor Trade Name:

Common Name: Bioabsorbable suture anchor

Classification Names: Biodegradable soft tissue fixation fastener

Proposed Class: Class II

Product Code:

Japan Japan Japan Janakar Janakar Janakar Janakar Janakar Janakar Janakar Janakar Janakar Janakar Janakar Janakar Janakar Janakar Jara Mari Mari Mari Mari Mari Mari Mari Mark MAI

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Summary of Safety and Effectiveness Bio-Mini Revo Suture Anchor 510(k) # _ December 16, 2005 Page 2 of 3

#### Predicate/Legally Marketed Devices I).

K042966 - Duet and Impact Suture Anchor (Linvatec Biomaterials) K030388 - Impact Suture Anchor (Linvatec Biomaterials) K020056 - Duet Suture Anchor (Linvatec Biomaterials) K050497 - BioScrew XtraLok (ConMed Linvatec) K020377 – BioStinger – V Bioabsorbable Meniscal Repair Device (ConMed Linvatec) K991715 - BioStinger -V Bioabsorbable Meniscal Repair Device (ConMed Linvatec)

#### E. Device Description

The Linvatec Bio-Mini-Revo™ suture anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with one non-absorbable, braided, ultrahigh molecular weight polyethylene suture. The Bio-Mini-Revo™ suture anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.

#### म् . Intended Use

The Bio-Mini Revo Suture Anchor ™ is intended for use in arthroscopic or open surgical procedures to reattach soft tissues to the bone.

#### C. Substantial Equivalence

The predicate devices are the previously cleared Linvatec Biomaterials Duet Suture Anchor (K020056, K042966) and Impact Suture Anchor (K030388, K042966), and ConMed Linvatec BioScrew XtraLok (K050497), Preloaded BioStinger Hornet (K020377), and BioStinger -V Bioabsorbable Meniscal Repair Device (K991715). These devices have substantially equivalent intended use, principles of operation and similar technological characteristics.

The difference when compared to Linvatec Biomaterials Duet Suture Anchor (K020056, K042966) and Impact Suture Anchor (K030388, K042966) is optional colored version. Production, the billet and machining of bioabsorbable implants are conducted in the same facility of Linvatec Biomaterials for all three anchors, Duet Suture Anchor (K020056, K042966), Impact Suture Anchor (K030388, K042966) and Bio-Mini-Revo. Polymer material is identical for all three implants, poly-96L/4D-lactide copolymer.

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Summary of Safety and Effectiveness Bio-Mini Revo Suture Anchor 510(k) # _ December 16, 2005 Page 3 of 3

The technological difference between the proposed device and the BioScrew Xtralok (K050497), Preloaded BioStinger Hornet (K020377), and the BioStinger -V (11030197), "Frendade Broair Device (K991715) is the material. The proposed Bio-111040000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 as the predicate devices listed above are manufactured from poly-L-lactide homopolymer. However, these devices are similar in that the D&C Violet #2 colorant is identical in the proposed device and these predicate devices.

The minor technological differences between Bio-Mini-Revo™ suture anchor and the predicate device do not raise any new issues of safety or effectiveness.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

Ms. Elizabeth Paul Manager, Regulatory Affairs ConMed Linvatec 11311 Concept Blvd. Largo, Florida 33773-4908

Re: K053561

Trade/Device Name: Bio-Mini-Revo™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: December 16, 2005 Received: December 22, 2005

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 adultcration.

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

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Page 2 – Ms. Elizabeth Paul

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. 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/dsma/dsmamain.html

Sincerely yours,
Huber Leunus

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K05-356/

Device Name: Bio-Mini Revo Suture Anchor

Indications for Use:

The Bio-Mini Revo Suture Anchor is intended to reattach soft tissue to bone in orders The Bio-Mini Revo Suure Anchor is mendou to reactions of open surgical procedures.
surgical procedures. The device may be used in either arther such as ligament surgical procedures. The device may be used in oratrach soft tissue, such as ligaments,
After the suture is anchored to the bone, it may be used to security stabilizes the da After the suture is anchored to the bone, it may be used to reasm thereby stabilizes the damaged tendoms, or joint capsuics, to the bone. The bacale anches of the bealing period.

ાર Prescription Use X (Part 21 CFR 801 subpart D)

Over-the-Counter Use_ (Part 21 CFR 807 subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division of General. Restorative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________