← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K100159 # SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR (K100159) _Smith & Nephew Inc., Endoscopy Div. · MBI · Apr 19, 2010 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K100159 ## Device Facts - **Applicant:** Smith & Nephew Inc., Endoscopy Div. - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Apr 19, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Smith & Nephew TWINFIX Ultra Ti Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs . Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment ## Device Story Titanium alloy suture anchor; preloaded with suture; preassembled on stainless steel inserter. Used by orthopedic surgeons in clinical/OR settings for soft tissue-to-bone reattachment. Device inserted into bone; provides fixation for sutures used to secure soft tissue. Benefits include secure tissue reattachment during reconstructive or repair procedures. Output is mechanical fixation of soft tissue. ## Clinical Evidence Bench testing only. Non-clinical testing evaluated insertion and pull-out strength. Results demonstrate performance is substantially equivalent to the predicate TWINFIX Ultra PK suture anchor. ## Technological Characteristics Titanium alloy suture anchor; diameters 4.5, 5.5, 6.5 mm. Preloaded with suture on stainless steel inserter. Mechanical fixation principle. Sterilization method not specified. ## 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 - Smith & Nephew TWINFIX Ultra PK Suture Anchor ([K093226](/device/K093226.md)) - TWINFIX Ti 5.0 Suture Anchor ([K972326](/device/K972326.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}------------------------------------------------ K100159 # SECTION IV # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION As required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based. # Smith & Nephew TWINFIX Ultra PK Suture Anchor Date Prepared: January 19, 2010 # A. Submitter's Name: Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810 # B. Company Contact Christina Flores Regulatory Affairs Specialist II Phone: (508) 261-3705 FAX: (508) 261-3620 # C. Device Name Trade Name: TWINFIX Ultra Ti Suture Anchor Common Name: Suture Anchor Classification Name: 888.3040 Smooth or Threaded Metal Bone Fixation Fasteners # D. Predicate Devices The Smith & Nephew TWINFIX Ultra Ti Anchor is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew TWINFIX Ultra PK Suture Anchor cleared via K093226 and the TWINFIX Ti 5.0 Suture Anchor cleared via K972326. #### E. Description of Device The TWINFIX Ultra Ti is a suture anchor manufactured from Titanium alloy and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The anchor is preloaded with suture preassembled onto a stainless steel inserter. {1}------------------------------------------------ ### F. Intended Use The Smith & Nephew TWINFIX Ultra Ti Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: - Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs . Deltoid repairs Rotator cuff tear repairs Biceps tenodesis - Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis. # Elbow: - Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment # G. Comparison of Technological Characteristics The Smith & Nephew TWINFIX Ultra Ti suture anchor is substantially equivalent in intended use and technological characteristics to its currently marketed predicate devices, the Smith & Nephew TWINFIX Ultra PK (K093226) and the TWINFIX Ti 5.0 (K972326). The minor modifications to length, thread profile, and anchor/inserter interface do not introduce any new questions of safety or effectiveness. # H. Summary Performance Data The critical functional parameters for suture anchors are adequate insertion and fixation (pull-out) strength. Non-clinical testing that included insertion and pull-out strength was performed and the results demonstrate that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra Ti suture anchor are substantially equivalent to the predicate TWINFIX Ultra PK suture anchor, cleared via K093226. The testing also demonstrates that the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy. {2}------------------------------------------------ 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 three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 # APR 1 9 2010 Smith & Nephew Inc., Endoscopy Division % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810 Re: K100159 Trade/Device Name: Smith & Nephew TWINFIX Ultra Ti Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fasteners Regulatory Class: II Product Code: MBI Dated: January 19, 2010 Received: January 20, 2010 Dear Ms. Flores: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 practice requirements as set {3}------------------------------------------------ ### Page 2 - Ms. Christina Flores 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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misoranding 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Barbara Vreeland Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known): Device Name: Smith & Nephew TWINFIX Ultra Ti Suture Anchor Indications For Use: The Smith & Nephew TWINFIX Ultra Ti Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: 10015 Shoulder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Jaut Son (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K100159 p / of / --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K100159](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K100159) **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