← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K020056 # DUET SUTURE ANCHOR (K020056) _Bionx Implants, Ltd. · HWC · Jun 26, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K020056 ## Device Facts - **Applicant:** Bionx Implants, Ltd. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jun 26, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. ## Device Story Duet Suture Anchor is a threaded, bioabsorbable screw-in device; preloaded on a disposable inserter with two non-absorbable braided polyester #2 sutures. Used by surgeons in OR for arthroscopic or open soft tissue-to-bone reattachment. Device provides mechanical fixation during healing; copolymer retains 90% strength for 20 weeks; resorbs over several years. Surgeon inserts anchor into bone; sutures are used to secure soft tissue. Benefits include stable fixation during healing phase; gradual strength loss matches tissue repair progression. Material is inert, non-collagenous, non-pyrogenic. ## Clinical Evidence No clinical data provided; substantial equivalence based on bench testing and comparison of technological characteristics to predicate devices. ## Technological Characteristics Bioabsorbable screw-in anchor; 6.0mm diameter, 16.5mm length. Material: Self-Reinforced (96/4D) poly-L/D-lactide copolymer. Preloaded with two non-absorbable braided polyester #2 sutures. Sterile, single-use disposable inserter. Mechanical properties: retains 90% strength through 20 weeks; complete resorption over several years. ## 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 - SmartAnchor ([K972783](/device/K972783.md)) - Bankart Tack ([K973849](/device/K973849.md)) - Contour Labral Nail ([K992567](/device/K992567.md), [K003970](/device/K003970.md)) - BioCuff ([K001378](/device/K001378.md)) - BioCuff C ([K013057](/device/K013057.md)) - Bio-Absorbable Corkscrew ([K990361](/device/K990361.md)) - Bio-Absorbable Corkscrew Suture Anchor ([K990987](/device/K990987.md)) - Bio-Absorbable CorkScrew Suture Anchor ([K003227](/device/K003227.md)) - TissueTak ([K990340](/device/K990340.md)) - BioROC EZ ([K973381](/device/K973381.md)) - RC Multi-Suture Anchor ([K992458](/device/K992458.md)) - Sutureless Anchor ([K984490](/device/K984490.md)) - Biologically Quiet Biosphere ([K963396](/device/K963396.md)) - Biologically Ouiet Mini-Screw Suture Anchor ([K960555](/device/K960555.md)) - Bio-Anchor ([K964805](/device/K964805.md), [K963369](/device/K963369.md), [K983186](/device/K983186.md)) - BioRC Anchor ([K990110](/device/K990110.md)) - Panalok ([K950272](/device/K950272.md)) - Panalok RC ([K970896](/device/K970896.md)) - Absorbable Toggle Anchor ([K964013](/device/K964013.md)) - Suretac 6.0, 8.0 ([K911837](/device/K911837.md)) - De Puy Dupont Phantom Suture Anchor ([K964921](/device/K964921.md)) ## Reference Devices - SmartNail ([K993074](/device/K993074.md)) - Meniscus Arrow ([K993453](/device/K993453.md)) - SmartScrew ACL ([K993073](/device/K993073.md)) - SmartScrew ([K012001](/device/K012001.md)) - The Wedge ([K000616](/device/K000616.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}------------------------------------------------ K020056 page 193 JUN 2 6 2002 # 510(k) Summary Bionx Implants Inc. Duet Suture Anchor™ # Submitter's Name, Address, Telephone Number, and Contact Person Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, PA 19422 Gerard S. Carlozzi Contacts: President and Chief Executive Officer Phone: (215) 643-5000 (215) 653-0984 Facsimile: > Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5629 #### Date prepared: December 18, 2001 #### Name of the device: | A. | Trade or Proprietary Name: | Duet™ Suture Anchor | |----|----------------------------|--------------------------------------------------------| | B. | Common Name: | Bioabsorbable suture anchor | | C. | Classification Name: | Biodegradable soft tissue fixation
fastener (87MAI) | | D. | Device Product Code: | MAI | | E. | Regulatory Classification: | Class II | #### Predicate Device: The Duet™ Suture Anchor is intended for use in the reattachment of soft tissue to bone by arthroscopy or direct visualization. This indication is substantial equivalent with Bionx Implants Inc. SmartAnchor (K972783), Bankart Tack (K973849), {1}------------------------------------------------ Contour Labral Nail (K992567, K003970), BioCuff™ (K001378) and BioCuff™ C (K013057), Arthrex Inc. Bio-Absorbable Corkscrew (K990361) Bio-Absorbable Corkscrew Suture Anchor (K990987), Bio-Absorbable CorkScrew Suture Anchor (K003227) and TissueTak (K990340), Innovasive Devices, Inc. BioROC EZ (K973381), RC Multi-Suture Anchor (K992458) and Sutureless Anchor (K984490), Instrument Makar, Inc,Biologically Quiet Biosphere (K963396) and Biologically Ouiet Mini-Screw Suture Anchor (K960555), Linvatec Corporation Bio-Anchor (K964805, K963369, K983186) and BioRC Anchor (K990110), Mitek Surgical Products Panalok (K950272), Panalok RC (K970896) and Absorbable Toggle Anchor (K964013), Acufex Inc. Suretac 6.0, 8,0 (K911837) and DePuy Inc. De Puy Dupont Phantom Suture Anchor (K964921). ## Intended Use: The Bionx Duet™ Suture Anchor is a bioabsorbale screw-in suture anchor that is preloaded on a disposable inserter device with two non-absorbable, braided, polyester #2 sutures. The Duet™ Suture Anchor is manufactured from Self-Reinforced (96/4D) PLA Copolymer that retains 90% strength through 20 weeks and completely resorbs over a period of several years in vivo. The unique Self-Reinforced Copolymer provides high initial mechanical strength required for insertion and through the healing phase (20 weeks) with complete absorption occurring over several years. The unique absorption profile of the Copolymer allows the anchor to gradually loose strength as the collagen fibers of the repair form and gain strength. The Copolymer is inert, non-collagenous and non-pyrogenic through the absorption process. The Duet™ Suture Anchor is indicated for use in arthroscopic or open surgical procedures to reattach soft tissue to the bone. The Duet™ Suture Anchor is contraindicated in the following conditions: - Surgical procedures other than those listed. 1. - Conditions that may compromise Anchor fixation (osteopenic, comminuted 2. bone, pathologic conditions in the soft tissues to be attached, etc.) - Conditions that may retard healing (poor blood supply, past or potential 3. infection, etc). - Active infection. 4. - Conditions that may limit the patients ability or willingness to restrict റ് activities or follow directions during the healing period. - Foreign body sensitivity to materials. 6. - 7. Patients with suspected or known allergy to the implant or suture materials. # Device Description: Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D- {2}------------------------------------------------ page 3 of 3 lactide copolymer. The poly-L/D-lactide material equals the raw material used in previously cleared Bionx Implants Inc. SmartNail™ (K993074), Meniscus Arrow™ (K993453), SmartScrew ACL™ (K993073), SmartScrew (K012001), The Wedge™ (K000616), Contour Labral Nail (K003970), BioCuff (K001378) and BioCuff C (K013057). ## Substantial Equivalence: All of these devices have the same intended use and principles of operation and very similar technological characteristics. Furthermore, the minor technological differences between the Bionx Implants Inc. Duet™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness. {3}------------------------------------------------ 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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 2 6 2002 Ms. Tuija Annala Director Quality and Regulatory Affairs Bionx Implants Ltd. P.O. Box 3. FIN-33721 Tampere, Finland Re: K020056 Trade/Device Name: Duet™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 5, 2002 Received: April 8, 2002 Dear Ms. Annala: 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 {4}------------------------------------------------ ### Page 2 - Ms. Tuija Annala (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. 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N-Mullene for Celia M. Witten, Ph.D., M.D. 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 {5}------------------------------------------------ # INDICATIONS FOR USE 510(K) Number (if known): Device Name: Duet™ Suture Anchor #### Indications for Use: The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. The Bionx Duet™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3)Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6)Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials. (Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) No OR Over-The-Counter Use Mark A. Millman vision Sign-Division of Genat 91. Restorative and Neurological Devices 510(k) Number. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K020056](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K020056) **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