← Product Code [DZL](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL) · K992623 # MITEK MINI ANCHOR (K992623) _Mitek Products · DZL · Nov 2, 1999 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K992623 ## Device Facts - **Applicant:** Mitek Products - **Product Code:** [DZL](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL.md) - **Decision Date:** Nov 2, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4880 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use Shoulder: Bankart Repair Ankle: Midfoot Reconstructions Foot: Hallux Valgus Reconstruction Wrist: Scapholunate Ligament Reconstruction Hand: Ulnar or Lateral Collateral Ligament Reconstruction Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence The Mitek Mini Anchor is also indicated for the repair, repositioning or reattachment of soft tissues, ligaments and tendons to the mandible for surgical stabilization of the TMJ articular disc. ## Device Story Sterile, disposable bone anchor; titanium alloy shaft with nickel-titanium shape-memory alloy arcs; pre-loaded with polyester suture. Used by surgeons for soft tissue-to-bone fixation in orthopedic and TMJ procedures. Device functions by anchoring into bone to provide stabilization for ligaments, tendons, or soft tissues. Clinical benefit includes surgical stabilization of anatomical structures, such as the TMJ articular disc or ligaments in extremities. Operated by physicians in surgical settings. ## Clinical Evidence Bench testing included pull-out force measurements in preserved human cadaver mandibular condyles and strength comparisons against bone tunnels in fresh frozen human mandibles. Long-term clinical follow-up evaluation was conducted to assess osteointegration and positional stability for the TMJ indication. ## Technological Characteristics Titanium alloy shaft; nickel-titanium shape-memory alloy arcs; polyester suture. Mechanical fixation device. No software or energy source. ## Regulatory Identification An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement. ## Predicate Devices - Mitek Mini Anchor ([K921873](/device/K921873.md)) - Mitek Mini Anchor ([K930892](/device/K930892.md)) - Mitek Mini Anchor ([K936311](/device/K936311.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}------------------------------------------------ K992623 # 510(k) Summary | Trade Name: | Mitek Mini Anchor | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Mitek Products
60 Glacier Drive
Westwood, MA 02090
Registration #1221934 | | Contact: | Paula E. Bulger
Manager, Regulatory Affairs
Mitek Products
60 Glacier Drive
Westwood, MA 02090
Phone: (781) 251-2700
Fax: (781) 461-9166 | | Device Generic Name: | Staple, Fixation, Bone | | Classification: | According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II. | | Product Code: | JDR (21 CFR 888.3030) | | Predicate Devices: | K921873 - Mitek Mini Anchor
K930892 - Mitek Mini Anchor
K936311 - Mitek Mini Anchor | Product Description: The device described in this 510(k) is a sterile, disposable bone anchor consisting of a titanium alloy shaft with nickel-titanium shape-memory alloy arcs. The anchor is supplied pre-loaded with a polyester suture. #### Indications for Use: Mitek Mini Anchors have been found substantially equivalent in previous Premarket Notifications for the following indications: | | Shoulder: Bankart Repair | |--------|------------------------------------------------------------------------------------------| | Ankle: | Midfoot Reconstructions | | Foot: | Hallux Valgus Reconstruction | | Wrist: | Scapholunate Ligament Reconstruction | | Hand: | Ulnar or Lateral Collateral Ligament Reconstruction | | Pubis: | Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence | This current 510(k) allows modification of the Mini Anchor labeling in order to add the following indication: For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc. ### Safety and Performance: The following safety and performance data has been provided to support substantial equivalence of the Mini Anchor for the expanded indication: {1}------------------------------------------------ | Performance testing: | Pull-out force (preserved human cadaver mandibular condyle)
Strength comparison (Mini Anchor vs. bone tunnels in fresh frozen human mandible) | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Long-term stability: | Evaluation of osteointegration and positional stability in Mini Anchors used for new indication | | Clinical data: | Long-term patient follow-up evaluation of Mini Anchors used for new indication | #### Conclusion: Based on safety and performance data, similarities in design, operating principle, materials, biocompatibility and sterilization method, the Mitek Mini Anchor with expanded indication has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three wavy lines forming the profile of a person's head and shoulders. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Nov - 2 1999 Ms. Paula E. Bulger Regulatory Affairs Manager Mitek Products Ethicon, Inc. 60 Glacier Drive Westwood, MA 02090 Re: K992623 > Mitek Mini Anchor Trade Name: Requlatory Class: II Product Code: DZL Dated: August 4, 1999 Received: August 5, 1999 Dear Ms. Bulger: 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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 {3}------------------------------------------------ Page 2 - Ms. Bulger 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. 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Page _ 899623 510(k) Number (if known): __ Device Name: ___Mitek Mini Anchor_ Indications for Use: | Shoulder: | Bankart Repair | |-----------|---------------------------------------------------------------------------------------------| | Ankle: | Midfoot Reconstructions | | Foot: | Hallux Valgus Reconstruction | | Wrist: | Scapholunate Ligament Reconstruction | | Hand: | Ulnar or Lateral Collateral Ligament Reconstruction | | Pubis: | Fixation in the pubis for bladder neck suspension to resolve stress
urinary incontinence | The Mitek Mini Anchor is also indicated for the repair, repositioning or reattachment of soft tissues, ligaments and tendons to the mandible for surgical stabilization of the TMJ articular disc. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________ Susan Runny (Division Sign-Off) Division of Dental, Infection Co and General Hospital Devi 510(k) Number . 000007 . --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K992623](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZL/K992623) **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