(121 days)
Not Found
No
The description focuses on the mechanical properties and surgical application of a suture anchor system, with no mention of AI or ML.
Yes.
The device is a suture anchor system used to fixate suture or soft tissue to bone, serving a therapeutic purpose in various musculoskeletal repairs.
No
The device is a suture anchor system used for fixating suture or soft tissue to bone during surgical repairs, not for diagnosing conditions.
No
The device description clearly states the system is comprised of a PEEK polymer and titanium suture anchor preloaded on a disposable inserter, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the ReelX STT Suture Anchor System is a device used to fixate suture or soft tissue to bone during surgical procedures. It is a physical implant used in vivo (within the body) during surgery.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical implant used for mechanical fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures:
Shoulder:
Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromio-Clavicular Separation Repair
Deltoid Repair
Capsular Shift/Capsulolabral Reconstruction
Knee:
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Patellar Tendon Repair
Posterior Oblique Ligament Repair
Illiotibial Band Tenodesis
Foot and Ankle:
Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair
Hallux Valgus Reconstruction
Midfoot Reconstruction
Metatarsal Ligament Repair
Elbow:
Biceps Tendon Reattachment
The ReelX STT Suture Anchor System is intended for single-use only.
Product codes
MBI
Device Description
The ReelX STT Suture Anchor System Line Extension (here forth referred to as the 3.9mm ReelX STT Suture Anchor) is an anchor designed to facilitate fixation of soft tissue to bone. The system is comprised of a PEEK polymer and titanium suture anchor preloaded on a disposable inserter. This anchor design allows the surgeon to adjust the tension of the tissue after the anchor has been inserted in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot and ankle, knee, and elbow.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical ultimate tensile strength testing was performed to characterize both the insertion strength and fixation strength of the 3.9mm ReeIX STT Suture Anchor as compared to the predicate devices identified within this premarket notification. The results of this testing indicate that the performance of the 3.9mm ReelX STT Suture Anchor System is substantially equivalent to the predicate devices, and the subject anchors will function within the intended use.
Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
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K120824(1/3)
510(k) Summary of Safety and Effectiveness
JUL 18 2012
| Proprietary Name: | Stryker ReelX STTTM Suture Anchor System Line
Extension |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener
21 CFR §888.3040 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | MBI: Fastener, Fixation, Nondegradable, Soft Tissue |
| For Information Contact: | Kelly Kucharczyk
Regulatory Affairs Associate
Howmedica Osteonics Corp.
3201 East 3rd Ave.
Denver, CO 80206
Phone: (303) 336-7285; Fax (303) 370-5775
Email: kelly.kucharczyk@stryker.com |
| Legally Marketed Devices to Which
Substantial Equivalence Is Claimed: | K090530 - Spin-Loc Suture Anchor System (legally
marketed as Stryker ReelX STT Suture Anchor)
K051219 - Arthrex PushLock
K970896 - DePuy Mitek Panalok Anchor |
| Date Prepared: | July 11, 2012 |
Purpose
Stryker currently offers a 5.5mm ReelX STT Suture Anchor (cleared as the Spin-Loc Suture Anchor System- K090530). This submission serves to introduce an additional 3.9mm ReelX STT Suture Anchor to the market.
Description
The ReelX STT Suture Anchor System Line Extension (here forth referred to as the 3.9mm ReelX STT Suture Anchor) is an anchor designed to facilitate fixation of soft tissue to bone. The system is comprised of a PEEK polymer and titanium suture anchor preloaded on a disposable inserter. This anchor design allows the surgeon to adjust the tension of the tissue after the anchor has been inserted in bone.
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Intended Use
The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures.
Indications
The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures:
| Shoulder: | Rotator Cuff Repair |
|---|---|
| Bankart Repair | |
| SLAP Lesion Repair | |
| Biceps Tenodesis | |
| Acromio-Clavicular Separation Repair | |
| Deltoid Repair | |
| Capsular Shift/Capsulolabral Reconstruction | |
| Knee: | Medial Collateral Ligament Repair |
| Lateral Collateral Ligament Repair | |
| Patellar Tendon Repair | |
| Posterior Oblique Ligament Repair | |
| Illiotibial Band Tenodesis | |
| Foot and Ankle: | Lateral Stabilization |
| Medial Stabilization | |
| Achilles Tendon Repair | |
| Hallux Valgus Reconstruction | |
| Midfoot Reconstruction | |
| Metatarsal Ligament Repair | |
| Elbow: | Biceps Tendon Reattachment |
The ReelX STT Suture Anchor is intended for single-use only.
Summary of Technologies
The proposed device is substantially equivalent to other commercially available soft tissue anchors in regard to intended use. design. materials of construct, performance attributes, and operational principles. The following devices are examples of predicate systems: the Spin-Loc Suture Anchor System (marketed as and here forth referred to as the 5.5mm ReelX STT Suture Anchor) and the Arthrex PushLock.
2
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Non-Clinical Testing
Non-clinical ultimate tensile strength testing was performed to characterize both the insertion strength and fixation strength of the 3.9mm ReeIX STT Suture Anchor as compared to the predicate devices identified within this premarket notification. The results of this testing indicate that the performance of the 3.9mm ReelX STT Suture Anchor System is substantially equivalent to the predicate devices, and the subject anchors will function within the intended use.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The 3.9mm ReeIX STT Suture Anchor System is substantially equivalent to the predicate devices identified in this premarket notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Corporation % Ms. Kelly Kucharczyk Regulatory Affairs Associate 3201 East 310 Avenue Denver, Colorado 80206
JUL 18 2012
Re: K120824
Trade/Device Name: Stryker ReelX STT™ Suture Anchor System Line Extension Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasterner Regulatory Class: II Product Code: MBI Dated: June 29, 2012 Received: July 01, 2012
Dear Ms. Kucharczyk:
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
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Page 2 - Ms. Kelly Kucharczyk
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 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/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 vours.
Erinell Keith
ArMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K1208241111)
Indications for Use
510(k) Number (if known): K120824
Device Name:
Stryker ReelX STT™ Suture Anchor System Line Extension
The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures:
Shoulder:
Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift/Capsulolabral Reconstruction
Knee:
Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Illiotibial Band Tenodesis
Lateral Stabilization Foot and Ankle: Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot Reconstruction Metatarsal Ligament Repair
Biceps Tendon Reattachment Elbow:
The ReelX STT Suture Anchor System is intended for single-use only.
| Prescription Use | xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
(Part 21 CFR 801 Subpart D) | AND/OR | 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) | | | | |
| Page 1 of 1 | | | (Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices | |
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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