BIOKNOTLESS ANCHOR

K002639 · Mitek Products · GAM · May 11, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K002639
• Device Name: BIOKNOTLESS ANCHOR
• Applicant: Mitek Products
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder: Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot: Hallux Valgus reconstruction. Elbow: Tennis elbow repair, Biceps tendon reattachment. Knee: Extra capsular repairs, reattachment of: Medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Device Story

BioKnotless Anchor is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly for soft tissue-to-bone fixation. Used by surgeons in clinical settings for orthopedic repairs (shoulder, ankle, foot, elbow, knee). Device consists of Polylactic Acid (PLA) anchor and braided long-term absorbable Panacryl suture. Surgeon inserts anchor into bone to secure soft tissue; provides mechanical fixation during healing. Benefits include secure tissue attachment and absorbable materials, reducing need for secondary removal. Single-patient use.

Clinical Evidence

Bench testing only. Included functional integrity testing and anchor pullout from bone testing. Biocompatibility testing performed per ISO-10933 standards.

Technological Characteristics

Materials: Polylactic Acid (PLA) anchor, braided long-term absorbable Panacryl suture. Form factor: Preloaded, disposable, sterile suture anchor/inserter assembly. Biocompatibility: ISO-10933 compliant.

Indications for Use

Indicated for soft tissue to bone fixation in patients requiring surgical repair of shoulder, ankle, foot, elbow, or knee structures, including ligament, tendon, and capsule reconstructions. Requires postoperative immobilization. Contraindications not specified.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Mitek - Knotless Anchor
• Mitek - PanalokTM Wedge Anchor

Submission Summary (Full Text)

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## MAY 1 1 2001

K002639

## SUMMARY OF SAFETY & EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Mitek Products is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Mitek Products choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the proposed BioKnotless Anchor is as follows:

| Trade Name: | BioKnotless Anchor |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Mitek Products<br>249 Vanderbilt Avenue<br>Norwood, MA 02062<br>Registration: 1221934 |
| Device Generic Name: | Appliance for reconstruction of bone to soft tissue |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device<br>classification is Class II, Performance Standards. |
| Predicate Devices: | Mitek - Knotless Anchor<br>Mitek - PanalokTM Wedge Anchor |

All of the devices mentioned above have been determined substantially equivalent by FDA.

Device Description: The device described in this 510(k) is a sterile, preloaded, disposable, absorbable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The product is designed for single patient use only. The anchor is constructed of Polylactic Acid (PLA) and the Panacry)™ suture is a braided long term absorbable suture.

Indications for Use: The BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder; Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair. Ankle; Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction. Foot; Hallux Valgus reconstruction. Elbow; Tennis elbow repair, Biceps tendon reattachment. Knee; Extra capsular repairs, reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Safety and Performance: Functional and integrity bench testing and Biocompatibility testing (according to the FDA guidance document, ODE Blue Book Memoradum #G95-1, 1995, Use of International Standard ISO-10933, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were performed, and the data supported the substantial equivalence of the BioKnotless 10 Anchor. Specifically, anchor pullout from bone testing and in vitro testing were conducted on the device.

Conclusion: Based on the Indications for Use, technological characteristics and safety and performance testing, the BioKnotless Anchor has been shown to be substantially eqivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary P. LeGraw Manager, Regulatory Affairs Mitek® Products 249 Vanderbilt Avenue Norwood, Massachussetts 02062

MAY 1 1 2001

Re: K002639

Trade Name: BioKnotless Anchor Regulation Number: 21 CFR 878.4493 Regulatory Class: Class II Product Code: GAM and MAI Dated: April 17, 2001 Received: April 20, 2001

Dear Ms.LeGraw:

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 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). 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 requirements, 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 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 - Ms. Mary P. LeGraw

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" (21CFR 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 [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Amthleelllertonfos

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

Enclosure

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510(k) Number (if known): _K002633

Device Name: BioKnotless Anchor_

## Indications for Use:

The Mitek BioKnotless Suture Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

..............................................................................................................................................................................

Shoulder: Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, midfoot reconstruction.

Foot: Hallux Valgus reconstruction

Elbow: Tennis elbow repair, Biceps tendon reattachment.

Knee: Extra capsular repairs, reattachment of: Medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

ihuro pis cum

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative
Division of General Devices Division of Gold Devices

510(k) Number K002639

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over-the -Counter Use _