← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K090615 # OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE (K090615) _Arthrocare Corp. · MBI · Jun 3, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K090615 ## Device Facts - **Applicant:** Arthrocare Corp. - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Jun 3, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Opus SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions ## Device Story Opus SpeedLock is a bone anchor with an inserter handle used for arthroscopic soft tissue-to-bone fixation. Operated by surgeons in clinical/OR settings. Device secures soft tissue to bone without requiring manual knots. Benefits include simplified surgical technique and secure fixation. No complex processing or software involved. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Bone anchor with inserter handle. Materials are well-characterized and used in predicate devices. Mechanical fixation device; no energy source, software, or connectivity. ## Regulatory 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 - Opus LabraLock P Knotless Fixation Device ([K061349](/device/K061349.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K090615 + 1/2. # 510(K) SUMMARY ARTHROCARE CORPORATION OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE JUN - 3 2009 ## General Information Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523 Sr. Manager, Regulatory Affairs Laura N. Kasperowicz March 5, 2009 Establishment Registration No .: 2951580 Contact Person: Date Prepared: Device Description Trade Name: Opus® SpeedLock™ Knotless Fixation Device Generic/Common Name: Bone Anchor, Fastener, Fixation, Soft Tissue Fastener, Fixation, Nondegradeable, Soft Tissue (Class II per 21 CFR 888.3040, Product code: MBI) Classification Name: ### Predicate Devices Opus LabraLock™ P Knotless Fixation Device K061349 (Cleared July 14, 2006) #### Product Description The Opus SpeedLock Knotless Fixation Device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures. #### Indications For Use The Opus SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions {1}------------------------------------------------ K090615 #2/2 ## 510(K) SUMMARY ## Substantial Equivalence By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The Opus SpeedLock Knotless Fixation Device is substantially equivalent to the existing Opus LabraLock P Knotless Fixation Device cleared by the Food & Drug Administration (K061349, cleared July 14, 2006). The differences between the Opus SpeedLock and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices. #### Summary and Reason for 510k Notification The purpose of this 510k is to notify the Food and Drug Administration of a new product, the Opus SpeedLock Knotless Fixation Device. This new product is substantially equivalent to the Opus LabraLock P Knotless Fixation Device originally cleared under K061349 (July 14, 2006). {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ArthroCare Corporation % Ms. Laura N. Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523 ## JUN - 3 2009 Re: K090615 Trade/Device Name: Opus® SpeedLock™ Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 5, 2009 Received: March 9, 2009 Dear Ms. Kasperowicz: 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing {3}------------------------------------------------ Page 2- Ms. Laura N. Kasperowicz 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Barbara Brenn Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number: K 090615 Device Name: Opus® SpeedLock™ Knotless Fixation Device Indications for Use: The Opus SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions X Prescription Use (Part 21 CFR 801 Subpart D) S AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) NO (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Onsta Division Si (Devision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K090615 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K090615](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K090615) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com