(65 days)
Not Found
No
The summary describes a mechanical suture anchor system made of PEEK and UHMWPE, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes.
The device is described as a "soft-tissue to bone fixation device" intended for "fixation of soft tissue to bone" in various parts of the body, indicating it is used for treatment and repair within the body.
No
The Crius PEEK Suture Anchor System is a device designed for the fixation of soft tissue to bone, not for diagnosing medical conditions. Its function is to physically attach tissue, which is a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components made of PEEK, UHMWPE, and stainless steel, and describes performance testing related to mechanical properties like insertion force, torque, pullout strength, and fatigue strength, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the fixation of soft tissue to bone". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (suture anchor) and instruments used for surgical insertion.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Reagents, calibrators, or controls typically associated with IVD tests.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder.
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot reconstruction, Metatarsal Ligament Repair
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular labral repair.
Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor)
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/ Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament repair, Iliotibial band tenodesis, Patellar realignment and tendon repairs
Elbow: Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
Hip: Abductor tendon repair
Crius PEEK Suture Anchor System (Helicoil Anchor)
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/ Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstruction, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Posterior oblique ligament repair, Iliotibial band tenodesis, Patellar realignment and tendon repairs
Elbow: Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment
Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
Crius PEEK Suture Anchor System (Pile Anchor)
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcromioClavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair/Tendon Repair, HALLUX Valgus Reconstruction, Mid-foot Reconstruction, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Acetabular Labral Repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Crius PEEK Suture Anchor System is a soft-tissue to bone fixation device, provided preloaded on a disposable inserter. Crius PEEK Suture Anchor System includes four types Thread-Fix Anchor, Thread-Fix Ultra Anchor, Helicoil Anchor and Pile Anchor. The device is available in varying profile diameters. The system consists of a suture anchor, suture (except for Pile Anchor), and insertion handle and insertion shaft) and is a sterile, single use device. The anchor body is manufactured from Polyetheretherketone(PEEK). The suture is made from ultra high molecular weight polyethylene (UHMWPE) available in white and blue/white colors. The blue dye used in the suture is Chromium-cobalt-aluminum oxide in accordance with 21 CFR 73.1015 regulations. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture. The insertion shaft is made from 304 stainless steel compliant with ISO 7153-1 and 630 stainless steel compliant with ISO 16061. The surgical instruments are provided non-sterile and shall be sterilized by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, hand, wrist, elbow, knee, hip and shoulder.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in accordance with ASTM F543-17, ASTM F1839-08, and the FDA Guidance 'Bone Anchors - Premarket Notification (510(k)) Submissions' (Issued on March 3,2020) between the subject device and predicate device. Specifically, the following tests were performed: insertion force testing, insertion torque testing, torsional strength testing, pullout strength testing, and fatigue strength testing. Acceptance criteria were based on similar sized predicate suture anchor devices and the results of the performance testing showed the subject device to have substantially equivalent performance compared to the predicate device. The subject devices meet the pyrogen limit specification (
§ 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.
0
January 31, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" stacked above the words "U.S. FOOD & DRUG ADMINISTRATION".
ZheJiang Decans Medical Devices Co., Ltd. Chen Liu RA No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District Jiaxing, Zhejiang 314031 China
Re: K243665
Trade/Device Name: Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 24, 2024 Received: November 27, 2024
Dear Chen Liu:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER EERREIRA -S
Christopher Ferreira, MS Assistant Director, Biomedical Engineer DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Crius PEEK Suture Anchor System (Thread-Fix Anchor);
Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor);
Crius PEEK Suture Anchor System (Helicoil Anchor);
Crius PEEK Suture Anchor System (Pile Anchor)
Indications for Use (Describe)
The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder.
| Crius PEEK Suture Anchor System (Thread-Fix Anchor) |
|---|
| Shoulder: |
| Rotator Cuff Repairs |
| Bankart Repair |
| SLAP Lesion Repair |
| Biceps Tenodesis |
| Acromio-Clavicular Separation Repair |
| Deltoid Repair |
| Capsular Shift or Capsulolabral Reconstruction |
| Foot/Ankle: |
| Lateral Stabilization |
| Medial Stabilization |
| Achilles Tendon Repair |
| Hallux Valgus Reconstruction |
| Midfoot reconstruction |
| Metatarsal Ligament Repair |
| Knee: |
| Anterior Cruciate Ligament Repair |
| Medial Collateral Ligament Repair |
| Lateral Collateral Ligament Repair |
| Patellar Tendon Repair |
| Posterior Oblique Ligament Repair |
| Iliotibial Band Tenodesis |
| Elbow: |
| Biceps Tendon Reattachment |
| Ulnar or Radial Collateral Ligament Reconstruction |
| Hip: |
| Capsular Repair |
| Acetabular labral repair. |
| Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor) |
| Shoulder: |
| Rotator Cuff Repairs |
| Bankart Repair |
| SLAP Lesion Repair |
| Biceps Tenodesis |
4
Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Foot/ Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Iliotibial band tenodesis Patellar realignment and tendon repairs Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Hip: Abductor tendon repair .............................................................................................................................................................................. Crius PEEK Suture Anchor System (Helicoil Anchor) Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Foot/ Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Iliotibial band tenodesis Patellar realignment and tendon repairs Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair Crius PEEK Suture Anchor System (Pile Anchor)
5
| Shoulder: | |
|---|---|
| Rotator Cuff Repair | |
| Bankart Repair | |
| SLAP Lesion Repair | |
| Biceps Tenodesis | |
| AcromioClavicular Separation Repair | |
| Deltoid Repair | |
| Capsular Shift or Capsulolabral Reconstruction Foot/ | |
| Ankle: | |
| Lateral Stabilization | |
| Medial Stabilization | |
| Achilles Tendon Repair | |
| Metatarsal Ligament Repair/Tendon Repair | |
| HALLUX Valgus Reconstruction | |
| Mid-foot Reconstruction | |
| Bunionectomy | |
| Knee: | |
| Medial Collateral Ligament Repair | |
| Lateral Collateral Ligament Repair | |
| Patellar Tendon Repair | |
| Posterior Oblique Ligament Repair | |
| Iliotibial Band Tenodesis | |
| Elbow: | |
| Biceps Tendon Reattachment | |
| Tennis Elbow Repair | |
| Ulnar or Radial Collateral Ligament Reconstruction | |
| Lateral Epicondylitis Repair | |
| Hand/Wrist: | |
| Scapholunate Ligament Reconstruction | |
| Ulnar or Radial Collateral Ligament Reconstruction | |
| Hip: | |
| Acetabular Labral Repair | |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart C) |
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/6/Picture/1 description: The image shows the logo for DECANS. The logo consists of a blue cube-like shape on the left, and the word "DECANS" in blue on the right. Below the word "DECANS" is the company name in Chinese, also in blue.
510K Summary
Crius PEEK Suture Anchor System
1.SUBMITTER
ZheJiang Decans Medical Devices Co., Ltd. No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing City, Zhejiang Province,314031 P.R. China Contact Person:Chen Liu,RA Telephone:+86 18132030804 Email:cliu@decansmd.com Date of Preparation:January/23/2025
2.SUBJECT DEVICE
Crius PEEK Suture Anchor System (Thread-Fix Anchor) Trade Name: Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor) Crius PEEK Suture Anchor System (Helicoil Anchor) Crius PEEK Suture Anchor System (Pile Anchor) Regulation Number:21 CFR 888.3040 Common Name:Suture Anchor Classification Name:fastener, fixation, nondegradable, soft tissue Regulatory Class: Class II Product Code:MBI
3.PREDICATE DEVICE
Primary Predicate Device K061665-Arthrex Corkscrew FT by ARTHREX, INC Additional Predicate Devices K 152566-TWINFIX Ultra PK Suture Anchor by SMITH & NEPHEW, INC. K113294-HEALICOIL PK Suture Anchor by SMITH & NEPHEW, INC. K101679-Arthrex PushLock Anchors by ARTHREX, INC K063479-Arthrex 2.5mm PushLock Anchors by ARTHREX, INC
4.DEVICE DESCRIPTION
The Crius PEEK Suture Anchor System is a soft-tissue to bone fixation device, provided preloaded on a disposable inserter. Crius PEEK Suture Anchor System includes four types Thread-Fix Anchor, Thread-Fix Ultra Anchor,Helicoil Anchor and Pile Anchor.The device is available in varying profile diameters. The system consists of a suture anchor, suture(except for Pile Anchor ), and insertion handle and insertion shaft) and is a sterile,single use device. The anchor body is manufactured from Polyetheretherketone(PEEK).The suture is made from ultra high molecular weight polyethylene(UHMWPE) available in white and blue/white colors. The blue dye used in the suture is Chromium-cobalt-aluminum oxide in accordance with 21
7
K243665
Image /page/7/Picture/1 description: The image contains a logo for DECANS. The logo consists of a blue cube-like shape on the left, with a stylized tree design on its faces. To the right of the cube, the text "DECANS" is written in blue, followed by two Chinese characters, also in blue, which likely represent the company's name in Chinese. The overall design is clean and modern, suggesting a company that is forward-thinking and innovative.
CFR 73.1015 regulations. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture. The insertion shaft is made from 304 stainless steel compliant with ISO 7153-1 and 630 stainless steel compliant with ISO 16061. The surgical instruments are provided non-sterile and shall be sterilized by the end user.
5.INDICATION FOR USE
The Crius PEEK Suture Anchor System is intended for the fixation of soft tissue to bone in the foot,ankle,hand,wrist,elbow,knee,hip and shoulder.
Thread-Fix Anchor
Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Knee: Anterior Cruciate Ligament Repair Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis
Foot/Ankle: Lateral Stabilization Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot reconstruction Metatarsal Ligament Repair
Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular Repair Acetabular labral repair.
Thread-Fix Ultra Anchor
- Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Knee: Medial collateral ligament repair Lateral collateral ligament repair
Foot/ Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Elbow: Ulnar or radial collateral ligament reconstructions
8
K243665
Image /page/8/Picture/1 description: The image contains a logo for DECANS. The logo consists of a blue cube-like shape on the left and the word "DECANS" in blue on the right. Below the word "DECANS" are three Chinese characters, also in blue. The cube-like shape appears to be a stylized representation of a tree or plant.
Posterior oblique ligament repair Iliotibial band tenodesis Patellar realignment and tendon repairs Hip: Abductor tendon repair
Lateral epicondylitis repair Biceps tendon reattachment
Helicoil Anchor
Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Knee: Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Iliotibial band tenodesis Patellar realignment and tendon repairs Hip: Gluteal tendon repairs - Gluteus medius and gluteus minimus repair
Foot/ Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Pile Anchor
Shoulder: Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis AcromioClavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction Knee: Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Iliotibial Band Tenodesis Hand/Wrist:
Foot/Ankle: Lateral Stabilization Medial Stabilization Achilles Tendon Repair Metatarsal Ligament Repair/Tendon Repair Hallux Valgus Reconstruction Mid-foot Reconstruction Bunionectomy
Elbow: Biceps Tendon Reattachment Tennis Elbow Repair Ulnar or Radial Collateral Ligament Reconstruction Lateral Epicondylitis Repair Hip:
9
Image /page/9/Picture/1 description: The image contains a logo for DECANS. The logo consists of a blue cube-like shape on the left and the word "DECANS" in blue on the right. Below the word "DECANS" are two Chinese characters, also in blue. The cube-like shape appears to be made up of smaller cubes or geometric shapes.
Scapholunate Ligament Reconstruction Acetabular Labral Repair Ulnar or Radial Collateral Ligament Reconstruction
6.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject Crius PEEK Suture Anchor System has the same intended use,design features materials, and sterilization methods as the identified predicate devices. Any technological differences between the subject and predicate devices are considered minor and do not raise different types of questions concerning safety and effectiveness.
7.PERFORMANCE DATA
Performance testing was conducted in accordance with ASTM F543-17, ASTM F1839-08, and the FDA Guidance 'Bone Anchors - Premarket Notification (510(k)) Submissions' (Issued on March 3,2020) between the subject device and predicate device. Specifically, the following tests were performed: insertion force testing, insertion torque testing, torsional strength testing, pullout strength testing, and fatigue strength testing. Acceptance criteria were based on similar sized predicate suture anchor devices and the results of the performance testing showed the subject device to have substantially equivalent performance compared to the predicate device. The subject devices meet the pyrogen limit specification (