OIC Suture Anchor System
Device Facts
| Record ID | K182736 |
|---|---|
| Device Name | OIC Suture Anchor System |
| Applicant | The Orthopaedic Implant Company |
| Product Code | MBI · Orthopedic |
| Decision Date | Dec 28, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.
Device Story
OIC Suture Anchor System comprises PEEK screw-in anchors and stainless steel/aluminum surgical instruments (driver, punch/tap, threader). Used by orthopedic surgeons in clinical/OR settings to reattach soft tissue to bone. Anchor features eyelet for surgeon-supplied sutures. Principle of operation: mechanical fixation of soft tissue to bone via screw-in anchor. Facilitates healing by securing tissue during repair procedures. System does not include sutures.
Clinical Evidence
Bench testing only. Mechanical testing conducted to verify suture anchor performance characteristics for intended orthopedic fixation procedures.
Technological Characteristics
Anchors: PEEK plastic. Instruments: Stainless steel, aluminum. Form factor: 15mm diameter screw-in anchor with eyelet. Energy source: None (manual). Sterilization: Not specified.
Indications for Use
Indicated for soft tissue-to-bone fixation in shoulder (rotator cuff repair, biceps tenodesis), elbow (biceps tendon reconstruction), and knee (ligament/tendon repairs including LCL, MCL, posterior oblique, patellar, and iliotibial band) procedures.
Regulatory Classification
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
Submission Summary (Full Text)
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December 28, 2018
The Orthopaedic Implant Company Douglas Fulton Ouality and Operations Manager 770 Smithridge Drive #400 Reno, Nevada 89502
Re: K182736
Trade/Device Name: OIC Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 28, 2018 Received: November 29, 2018
Dear Mr. Fulton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182736
Device Name OIC Suture Anchor System
Indications for Use (Describe)
The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis.
Elbow - Biceps tendon reconstruction.
Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.
Type of Use (Select one or both, as applicable)
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------------------------------------------|
| <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510(k) Summary
Prepared 11/28/2018
Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Drive. Suite 400 Reno, NV 89502
Contact: Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com
Device Identification: Trade Name: OIC Suture Anchor System Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue Classification: Class II, 21 CFR 888.3040 Panel: Orthopedic Product Code: MBI
Indications for Use: The OIC Suture Anchor System is intended for fixation of soft tissue to bone and will support the following procedures: Shoulder - Rotator cuff repair, biceps tenodesis. Elbow - Biceps tendon reconstruction. Knee - Lateral collateral ligament repair, medial collateral ligament repair, posterior oblique ligament repair, patellar tendon repair, iliotibial band tendonesis joint capsule repair.
Device Description:
The OIC Suture Anchor System consists of anchors and instruments to aid in implantation. The anchors are a screwlike device manufactured from PEEK plastic which are implanted into bone. Each anchor is 15mm in diameter and has an eyelet at the top that is used as an attachment point for sutures are used to fasten soft tissues to facilitate healing. Sutures are not included in the system. Instruments include an anchor driver, 5.5mm punch/tap, suture threader and tray. The instruments are made from stainless steel and aluminum.
Comparison of Technological Characteristics (Substantial Equivalence): Primary predicate device: K113299 RoG Sports Medicine Suture Anchor Additional predicate: K173269 Kator Suture Anchor The OIC Suture Anchor System has the following similarities to those which previously received 510(k) concurrence: has the same intended use, uses the same operating principle, and incorporates the same or similar materials
Performance Testing:
Mechanical testing was conducted to ascertain that the suture acceptable characteristics for the intended uses.
Conclusion:
The OIC Suture Anchor System described in this submission is, in our opinion, substantially equivalent to the predicate devices.
