BIORC ANCHOR

{0}------------------------------------------------ May 13, 1999 #### 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 510(k) Summary of Safety and Effectiveness for the BioRC Anchor 510(k) Number K990770. #### A. Submitter Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 #### Company Contact B. Laura Seneff Manager, Regulatory Affairs #### C. Device Name | Trade Name: | : BioRC Anchor | |----------------------|------------------------------------| | Common Name | : BioAbsorbable Soft Tissue Anchor | | Classification Names | : None Assigned | Proposed Class/Device : Class II-87 MAI, Fastener Product Code Fixation, Biodegradable, Soft Tissue #### D. Predicate/Legally Marketed Devices Revo Suture Anchor Linvatec Corporation Suretac Acufex Pre-loaded Bio-Anchor Linvatec Corporation {1}------------------------------------------------ Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 Page 2 of 4 ### E. Device Description The BioRC Anchor is a cannulated, threaded, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly(L-lactide acid), which is used to attach soft tissue to bone. The device is preloaded on a disposable driver used to insert it into the bone. #### F. Intended Use This device is used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: ## Shoulder - 1. Bankart lesion repair - 2. SLAP lesion repairs - 3. Acromio-clavicular separation repairs - 4. Rotator cuff tear repairs - 5. Capsular shift or capsulolabral reconstructions - 6. Biceps tenodesis - 7. Deltoid repairs ### Foot and Ankle - 1. Hallux Valgus repairs - 2. Medial or lateral instability repairs/reconstructions - 3. Achilles tendon repairs/reconstructions - 4. Midfoot reconstructions ### Elbow, Wrist and Hand - 1. Scapholunate ligament reconstructions - 2. Ulnar or radial collateral ligament reconstructions - 3. Lateral and Medial Epicondylitis - 4. Biceps tendon reattachment {2}------------------------------------------------ Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 - -Page 3 of 4 ### Knee - 1. Extracapsular repairs and reattachments of: - a. medial collateral ligament - b. lateral collateral ligament - c. posterior oblique ligament or joint capsule to tibia - d. joint capsule closure to anterior proximal tibia - 2. Extracapsular reconstruction, iliotibial band tenodesis - 3. Patellar realignment and tendon repairs #### Bladder Neck Suspension 1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility. #### G. Substantial Equivalence The BioRC Anchor is substantially equivalent in design and intended use to the Revo Suture Anchor (Linvatec Corporation) and SureTac (Acufex). The BioRC Anchor is substantially equivalent in materials to the Preloaded Bio-Anchor Absorbable Suture Anchor (Linvatec Corporation). Testing has been done to prove safety and effectiveness of the device. The similarities/dissimilarities to the predicate are shown in the attached table. {3}------------------------------------------------ Summary of Safety and Effectiveness BioRC Anchor 510(k) # K990770 May 13, 1999 Page 4 of 4 .. . # CHART OF SIMILARITIES AND DISSIMILARITIES | Company | Device Name | Intended Use | Material | Single-Use<br>Reusable | Method of<br>Sterilization | Design | |------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------------------------| | NEW<br>PRODUCT<br>Linvatec<br>Corp. | BioRC Anchor | Soft tissue to bone fixation for<br>shoulder, knee, foot, ankle,<br>elbow, wrist, hand and bladder<br>neck suspension procedures. | Poly(L-lactic acid) | Sterile<br>Single-use | Ethylene<br>Oxide | 6mm x 22mm<br>Threaded,<br>cannulated device<br>with a head to<br>attach soft tissue to<br>bone. | | PREDICATE<br>Linvatec<br>Corp.<br>510(K)#<br>K963932 | Revo Suture<br>Anchor | Soft tissue to bone fixation for<br>shoulder, knee, foot, ankle,<br>elbow, wrist, hand and bladder<br>neck suspension procedures. | Titanium Alloy | Sterile<br>Single-use | Gamma Radiation | 2.5mm-5.2mm<br>length<br>Threaded device<br>that attaches soft<br>tissue to bone. | | PREDICATE<br>Acufex<br>510(K)#<br>K911837 | Suretac | Soft tissue to bone fixation. | Polyglyconate | Sterile<br>Single-use | Ethylene Oxide | 8mm x 16mm<br>Cannulated tack<br>with ribs to hold the<br>device in the bone. | | PREDICATE<br>Linvatec Corp<br>510(K)#<br>K983186 | Pre-loaded Bio-<br>Anchor | Soft tissue to bone fixation for<br>shoulder, knee, foot, ankle,<br>elbow, wrist, hand and bladder<br>neck suspension procedures. | Poly(L-lactic acid) | Sterile<br>Single-use | Ethylene Oxide | 3.5mm x 10.5mm<br>Ribbed device with<br>a loop at the<br>proximal end to<br>hold suture which<br>attaches the soft<br>tissue. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 30 1999 Ms. Laura Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 K990770 Re: Trade Name: BioRC Anchor Regulatory Class: II Product Code: MAI, HWC Dated: May 13, 1999 Received: May 14, 1999 Dear Ms. Seneff: 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 control provisions of the Act. The general control 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 (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. {5}------------------------------------------------ Page 2 - Ms. Laura Seneff 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. 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ May 13, 1999 Page 1 of 2 510(k) Number (if known): K990770 Device Name: BioRC Anchor Indications for Use: The BioRC Anchor is a bioabsorbable device used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: #### Shoulder - 1. Bankart lesion repair - 2. SLAP lesion repairs - 3. Acromio-clavicular separation repairs - 4. Rotator cuff tear repairs - 5. Capsular shift or capsulolabral reconstructions - 6. Biceps tenodesis - 7. Deltoid repairs #### Foot and Ankle - 1. Hallux Valgus repairs - 2. Medial or lateral instability repairs/reconstructions - 3. Achilles tendon repairs/reconstructions - 4. Midfoot reconstructions Elbow, Wrist and Hand - 1. Scapholunate ligament reconstructions - 2. Ulnar or radial collateral ligament reconstructions - 3. Lateral and Medial Epicondylitis - 4. Biceps tendon reattachment #### Knee - 1. Extracapsular repairs and reattachments of: - a. medial collateral ligament - b. lateral collateral ligament - c. posterior oblique ligament or joint capsule to tibia - d. joint capsule closure to anterior proximal tibia - 2. Extracapsular reconstruction, iliotibial band tenodeşis - 3. Patellar realignment and tendon repairs **Prescription Use** **(Per 21 CFR 801.109)** | (Division Sign-Off) | | | | |-----------------------------------------|-------|--|--| | Division of General Restorative Devices | K9907 | | | | 510(k) Number | | | | {7}------------------------------------------------ Indications for Use (con't): Page 2 of 2 ### Bladder Neck Suspension 1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) A. colles