(30 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biological safety of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a suture anchor used to attach soft tissue to bone, which is a surgical fixation device rather than a therapeutic one designed to treat a disease or condition through non-surgical means. It provides mechanical support for repair rather than actively curing or mitigating a condition.
No
The device is a PEEK Suture Anchor used for attachment of soft tissue to bone, serving as a fixation point for soft tissue repair, not for diagnosing conditions.
No
The device description clearly states it consists of an implantable anchor and anchor tip, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "attachment of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details an implantable anchor and driver used for fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a surgical implant used for mechanical fixation within the body.
N/A
Intended Use / Indications for Use
The X-Twist PEEK Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avul Un Report Li
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
Product codes
MBI
Device Description
The X-Twist PEEK Suture Anchor consists of an implantable anchor and anchor tip that are provided assembled to a driver. Retention suture(s) or suture tapes(s) are preloaded through the driver cannulation to secure the anchor tip onto the driver shaft. The anchor tip can be loaded with additional suture(s) or suture tapes(s) if needed for the intended surgical procedure. Clockwise rotation of the driver allows for advancement of the fully threaded anchor and anchor tip into the prepared bone socket to serve as the point of fixation for soft tissue repair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Foot/Ankle, Elbow, Hand/Wrist
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
Benchtop testing was performed to evaluate cycle loading and elongation, insertion torque, and anchor pullout force. The testing was performed using the same methods and protocols as that used for the predicate devices. The results of the testing met the defined acceptance criteria and were assessed against the results obtained with the predicate devices to determine substantial equivalency for design and performance.
Final devices were subjected to bacterial endotoxin testing in accordance with USP . The results of the bacterial endotoxin test met the requirements of the FDA-recognized standards USP and USP .
Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices.
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.
0
May 19, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Parcus Medical LLC Calen Souther, MS Senior Specialist, Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243
Re: K221135
Trade/Device Name: X-Twist PEEK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: April 15, 2022 Received: April 19, 2022
Dear Calen Souther:
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 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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 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 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-regulatoryassistance/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.
For:
Laura C. Rose, Ph.D. Assistant Director 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221135
Device Name
X-Twist PEEK Suture Anchor
Indications for Use (Describe)
The X-Twist PEEK Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avul Un Report Li
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
| 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) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
The information contained herein is being provided in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | May 17, 2022 |
|---|---|
| Applicant: | Parcus Medical, LLC. |
| 6423 Parkland Dr. | |
| Sarasota, FL 34243 | |
| USA | |
| Official Correspondent: | Calen Souther, MS |
| Senior Specialist, Regulatory Affairs | |
| Phone: (770) 616-1389 | |
| Email: csouther@anika.com | |
| Trade/Proprietary Name: | X-Twist PEEK Suture Anchor |
| Common Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Regulation Name: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | MBI |
| Predicate Device Information: | Parcus Slik Anchor - K170327 - cleared March 30, 2017 |
| Parcus Twist PEEK Suture Anchor – K120942 – cleared April 20, 2012 | |
| Reason for 510(k) submission: | The purpose of this Special 510(k) is to obtain clearance for the X-Twist PEEK |
| Suture Anchor, as an extension of the Parcus suture anchor portfolio, for | |
| use in the fixation of soft tissue to bone. | |
| Description of Device: | The X-Twist PEEK Suture Anchor consists of an implantable anchor and |
| anchor tip that are provided assembled to a driver. Retention suture(s) or | |
| suture tapes(s) are preloaded through the driver cannulation to secure the | |
| anchor tip onto the driver shaft. The anchor tip can be loaded with | |
| additional suture(s) or suture tapes(s) if needed for the intended surgical | |
| procedure. Clockwise rotation of the driver allows for advancement of the | |
| fully threaded anchor and anchor tip into the prepared bone socket to serve | |
| as the point of fixation for soft tissue repair. |
4
Device Characteristics
| | X-Twist PEEK Suture Anchor | Parcus Slik Anchor
Parcus Twist PEEK Suture Anchor |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
clearance | Subject Device | K170327
K120942 |
| Manufacturer | Parcus Medical | Parcus Medical |
| Common Name | Fastener, Fixation, Non-degradable, soft
tissue | Fastener, Fixation, Non-degradable, soft tissue |
| Regulation | 21 CFR 888.3040 | 21 CFR 888.3040 |
| Class Name | Smooth or threaded metallic bone fixation
fastener | Smooth or threaded metallic bone fixation
fastener |
| Class | Class II | Class II |
| Product Code | MBI | MBI |
| Indication for Use | The X-Twist PEEK Suture Anchors are
indicated for attachment of soft tissue to
bone. These products are intended for the
following indications: | The Parcus Slik Anchors and Twist PEEK Suture
Anchors are indicated for attachment of soft
tissue to bone. These products are intended for
the following indications: |
| | Shoulder: Rotator Cuff Repair,
Acromioclavicular Separation Repair, Bankart
Lesion Repair, Biceps Tenodesis, Capsular
Shift or Capsulolabral Reconstruction, Deltoid
Repair, SLAP Lesion Repair. | Shoulder: Rotator Cuff Repair, Acromioclavicular
Separation Repair, Bankart Lesion Repair, Biceps
Tenodesis, Capsular Shift or Capsulolabral
Reconstruction, Deltoid Repair, SLAP Lesion
Repair. |
| | Knee: Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair, Posterior
Oblique Ligament Repair, Extra Capsular
Reconstruction, Iliotibial Band Tenodesis,
Patellar Ligament and Tendon Avulsion
Repair. | Knee: Medial Collateral Ligament Repair, Lateral
Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Extra Capsular Reconstruction,
lliotibial Band Tenodesis, Patellar Ligament and
Tendon Avulsion Repair. |
| | Foot/Ankle: Lateral Stabilization, Medial
Stabilization, Midfoot Reconstruction, Achilles
Tendon Repair, Hallux Valgus Reconstruction,
Metatarsal Ligament Repair. | Foot/Ankle: Lateral Stabilization, Medial
Stabilization, Midfoot Reconstruction, Achilles
Tendon Repair, Hallux Valgus Reconstruction,
Metatarsal Ligament Repair. |
| | Elbow: Tennis Elbow Repair, Biceps Tendon
Reattachment. | Elbow: Tennis Elbow Repair, Biceps Tendon
Reattachment. |
| | Hand/Wrist: Scapholunate Ligament
Reconstruction, Ulnar or Radial Collateral
Ligament Reconstruction, TFCC. | Hand/Wrist: Scapholunate Ligament
Reconstruction, Ulnar or Radial Collateral
Ligament Reconstruction, TFCC. |
| Implant Material | LT1- PEEK
UHMWPE | LT1- PEEK
UHMWPE |
| Single use only | Yes | Yes |
| Sterility | Sterile, EO | Sterile, EO |
| Shelf-life | 5-years | 5-years |
5
Non-clinical Testing
Benchtop testing was performed to evaluate cycle loading and elongation, insertion torque, and anchor pullout force. The testing was performed using the same methods and protocols as that used for the predicate devices. The results of the testing met the defined acceptance criteria and were assessed against the results obtained with the predicate devices to determine substantial equivalency for design and performance.
Final devices were subjected to bacterial endotoxin testing in accordance with USP .
| Test | Test Article | Negative
Control | Standard
Curve | PPC | Acceptance
Criteria | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| USP and
Inhibition/
Enhancement
Single Lot
Validation for
the Kinetic
Turbidimetric
Limulus
Amebocyte
Lysate (LAL)
Test | Ten (10)
disassembled
devices, each
submerged in
1000ml LAL
reagent water
(LRW),
extracted at
room
temperature
for one (1)
hour | Sterile
LRW | Control
Standard
Endotoxin
(CSE) at
1.23,
0.25,
0.05, 0.01
EU/ml | Test
article
spiked
with
0.05
EU/ml | Standard
Curve
Correlation
Coefficient:
≥0.98
Neg. Control
Onset Time:
Onset time >
lowest Cal
Standard
PPC: 50-200%
Test Article
Endotoxin
Concentration:
≤20 EU/device | Standard Curve
Correlation
Coefficient:
1.00
Neg. Control
Onset Time:
6000 seconds
PPC: 58%
Test Article
Endotoxin
Concentration:
and USP .
Clinical Data
Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices.
Conclusion
The X-Twist PEEK Suture Anchor is substantially equivalent to the predicate devices in which the basic design features, materials, packaging, sterility, shelf life, and intended uses are the same.
The testing data and comparisons of the technological characteristics within this submission demonstrate that the subject device is substantially equivalent to the predicate devices when used in accordance with the intended use.