← Product Code [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI) · K093228 # SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR (K093228) _Smith & Nephew, Inc. · MBI · Dec 15, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K093228 ## Device Facts - **Applicant:** Smith & Nephew, Inc. - **Product Code:** [MBI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI.md) - **Decision Date:** Dec 15, 2009 - **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 PK 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 repairs/reconstructions Medial or lateral instability Achilles tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Metatarsal ligament/tendon repairs/reconstruction Midfoot reconstructions ## Device Story The TWINFIX Ultra PK is a screw-in suture anchor system used by orthopedic surgeons for soft tissue-to-bone reattachment. The device consists of a PEEK (polyetheretherketone) anchor preloaded with ultra-high molecular weight polyethylene suture, preassembled onto a stainless steel inserter. During surgery, the surgeon uses the inserter to drive the anchor into bone, securing the soft tissue. The device provides mechanical fixation to facilitate healing. It is intended for use in various orthopedic procedures, including rotator cuff, Bankart, and ligament repairs. The device is provided sterile for single-use. ## Clinical Evidence Bench testing only. Performance testing demonstrated that the insertion and fixation properties of the TWINFIX Ultra PK are substantially equivalent to the predicate device. ## Technological Characteristics Materials: PEEK (polyetheretherketone) anchor, ultra-high molecular weight polyethylene suture, stainless steel inserter. Design: Screw-in suture anchor. Sizes: 4.5, 5.5, and 6.5 mm diameters. Sterilization: Ethylene Oxide (EO). ## 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 - TWINFIX PK FT Suture Anchor ([K072875](/device/K072875.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}------------------------------------------------ # Traditional 510(k) Section IV # 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: October 14, 2009 ### A. Submitter's Name: Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810 ## B. Company Contact Christina Flores Regulatory Affairs Specialist II (508) 261-3705 Phone: FAX: (508) 261-3620 ## C. Device Name | Trade Name: | TWINFIX Ultra PK Suture Anchor | |----------------------|-------------------------------------------------| | Common Name: | Suture Anchor | | Classification Name: | Fastener, fixation, non-degradable, soft tissue | ## D. Predicate Devices The Smith & Nephew TWINFIX Ultra PK Anchor is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew TWINFIX PK FT Suture Anchor cleared via K072875. ## E. Description of Device The TWINFIX Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone) and is offered in diameters of 4.5, 5.5, and 6.5 mm sizes. The screw-in anchor is preloaded with ultra high molecular weight polyethylene suture preassembled onto a stainless steel inserter. Image /page/0/Picture/18 description: The image contains the word "MATION" in large, bold, black font. The text is simple and isolated against a white background. The word appears to be a fragment, possibly part of a larger word or phrase. 1093228 DEC 1 5 2009 {1}------------------------------------------------ #### F. Intended Use The Smith & Nephew TWINFIX Ultra PK 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 repairs/reconstructions Medial or lateral instability Achilles tendon repairs/reconstructions Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquious advancement Illiotibial band tenodesis. ### Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Metatarsal ligament/tendon repairs/reconstruction Midfoot reconstructions ## G. Comparison of Technological Characteristics | Device Characteristics | TWINFIX FT PK
Predicate Device | TWINFIX Ultra PK
Proposed Device | |------------------------------------------|-----------------------------------|-------------------------------------| | Device Design/Principles of
Operation | Tap-in/Screw-in anchor | Screw-in suture anchor | | Materials | PEEK with polyethylene
suture | PEEK with polyethylene
suture | {2}------------------------------------------------ | Sterilization Method | EO | EO | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Attachment of soft tissue to bone | Attachment of soft tissue to bone | | Indications for Use | Reattachment of soft tissue to bone in
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/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon
repairs/reconstruction
Knee:
Extra-capsular repairs:
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon
repairs:
Vastus medialis obliquious
advancement
Illiotibial band tenodesis.
Elbow:
Ulnar or radial collateral ligament
reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment | Reattachment of soft tissue to bone in
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/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon
repairs/reconstruction
Knee:
Extra-capsular repairs:
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon
repairs:
Vastus medialis obliquious
advancement
Illiotibial band tenodesis.
Elbow:
Ulnar or radial collateral ligament
reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment | # H. Summary Performance Data The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew TWINFIX Ultra PK suture anchor is substantially equivalent to the predicate TWINFIX FT PK suture anchor, cleared via K072875. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy. {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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, abstract manner with flowing lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 Smith & Nephew Inc., Endoscopy Division % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810 DEC 1 5 2009 Re: K093228 > Trade/Device Name: Smith & Nephew TWINFIX Ultra PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fasteners Regulatory Class: Class II Product Code: MBI Dated: October 14, 2009 Received: October 15, 2009 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. 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 {4}------------------------------------------------ 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, "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/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm. Sincerely yours. Joxutii 3 Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use Ko9 3228 510(k) Number (if known): Device Name: Smith & Nephew TWINFIX Ultra PK Suture Anchor Indications For Use: The Smith & Nephew TWINFIX Ultra PK 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 obliquious advancement Illiotibial band tenodesis. Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Prescription Use _ x_ AND/OR (Per 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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) | | |-----------------------------------|--------------------------------------------------------|--| | Division sign-off) | MXM | | | Division of Surgical, Orthopedic, | | | and Restorative Devices 510(k) Number K093228 P, lot 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K093228](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBI/K093228) **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