(31 days)
No
The device description and performance studies focus on the material composition, mechanical properties, and biocompatibility of a physical implant (suture anchor) and its delivery system. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is a surgical implant designed to attach soft tissue to bone, serving as a fixation device rather than a therapeutic one that directly treats a disease or condition.
No
The device is an implantable suture anchor used for the re-attachment of soft tissue to bone, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines physical components (anchor, anchor tip, driver assembly) made of materials like beta-TCP, PLGA, and PEEK. It also mentions the need for tools like a drill, awl, and bone tap. This indicates a hardware-based medical device, not a software-only one.
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 about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided text describes a surgical implant (suture anchor) used to attach soft tissue to bone within the body. It's a physical device used during surgery.
- Intended Use: The intended use clearly states it's for surgical procedures like rotator cuff repair, ACL repair, etc., which are all performed in vivo (within the body).
The description of the X-Twist Biocomposite Suture Anchor aligns with a Class II or Class III medical device used for surgical repair, not an IVD.
N/A
Intended Use / Indications for Use
The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:
Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction
Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The X-Twist Biocomposite Suture Anchor consists of the implants (anchor and anchor tip) and the anchor driver assembly. The anchor and anchor tip are provided assembled to the driver and sterile. The X-Twist Biocomposite anchor is molded using a composite of beta-TCP (beta-tricalcium-phosphate) and PLGA (poly-lactic-co-glycolic acid). The anchor tip is molded using PEEK (polyetheretherketone). The anchor is fully threaded, double-helical, cannulated, and has inline fenestrations on each quarter-turn face. The anchor tip is retained on the driver via retention suture(s) or suture tape(s) that are passed through the driver cannulation, looped over the retention bridge within the tip, and returned out the proximal end of the driver handle and cleated. These devices are to be used with a drill, awl, and/or bone tap. The X-Twist Biocomposite Suture Anchors are provided sterile and in 4.75mm, 5.5mm, or 6.25mm diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: The non-clinical testing was conducted to evaluate the biocompatibility and performance of the subject device. The testing was performed using the same methods and protocols as that used for the predicate devices. The results of the testing were assessed against the results obtained with the predicate devices to determine substantial equivalency for design, performance, and safety. Final devices were subjected to bacterial endotoxin testing in accordance with USP and USP .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
X-Twist PEEK Suture Anchor – K221135, Twist AP Suture Anchor - K183501
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Arthrex SwiveLock – K101823
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
September 18, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Parcus Medical Calen Souther Manager, Regulatory Affairs 6455 Parkland Drive Sarasota, Florida 34243
Re: K232513
Trade/Device Name: X-Twist Biocomposite Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: August 18, 2023 Received: August 18, 2023
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
1
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 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 (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 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,
Sara S. Thompson -S
For
Jesse Muir, 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
Indications for Use
510(k) Number (if known) K232513
Device Name X-Twist Biocomposite Suture Anchor
Indications for Use (Describe)
The X-Twist Biocomposite Suture Anchors are indicated for attachment of soft tissue to bone. These products are intended for the following indications:
Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromo-Clavicular Separation Repair, Deltoid Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Meniscal Root Repair, Secondary or adjunct fixation for ACL/PCL reconstruction or repair, MPFL Repair/Reconstruction
Elbow: Ulnar/Radial Collateral Ligament Reconstruction, Lateral Epicondylitis 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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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: | September 12, 2023 | | X-Twist Biocomposite Suture
Anchor | X-Twist PEEK Suture Anchor | Twist AP (Biocomposite) Suture
Anchor |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Parcus Medical, LLC.
6423 Parkland Dr.
Sarasota, FL 34243
USA | 510(k)
clearance | Subject Device | K221135 | K183501 |
| Official Correspondent: | Calen Souther, MS
Manager, Regulatory Affairs
Phone: (781) 457-9541
Email: csouther@anika.com | Manufacturer | Parcus Medical | Parcus Medical | Parcus Medical |
| Trade/Proprietary Name: | X-Twist Biocomposite Suture Anchor | Common Name | Fastener, fixation,
biodegradable, soft tissue | Fastener, fixation, non-
degradable, soft tissue | Fastener, fixation,
biodegradable, soft tissue |
| Common Name: | Fastener, fixation, biodegradable, soft tissue | Regulation | 21 CFR 888.3030 | 21 CFR 888.3040 | 21 CFR 888.3030 |
| Regulation Name: | Single/multiple component metallic bone fixation appliances and
accessories | Class Name | Single/multiple component
metallic bone fixation
appliances and accessories | Smooth or threaded metallic
bone fixation fastener | Single/multiple component
metallic bone fixation appliances
and accessories |
| Device Class: | Class II | Class | Class II | Class II | Class II |
| Regulation Number: | 21 CFR 888.3030 | Product Code | MAI | MBI | MAI |
| Product Code: | MAI | Indications for Use | The X-Twist Biocomposite
Suture Anchors are indicated
for attachment of soft tissue
to bone. These products are
intended for the following
indications: | 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 Twist AP Suture
Anchors are indicated for the
attachment of soft tissue to
bone. This product is intended
for the following indications: |
| Predicate Device Information: | X-Twist PEEK Suture Anchor – K221135 - cleared May 19, 2022
Twist AP Suture Anchor - K183501 - cleared March 15, 2019 | | Shoulder: Rotator Cuff
Repair, SLAP Lesion Repair,
Biceps Tenodesis, Acromio-
Clavicular Separation Repair,
Deltoid Repair | 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. |
| Reference Device Information: | Arthrex SwiveLock – K101823 – cleared January 7, 2011 | | Foot/Ankle: Lateral
Stabilization, Medial
Stabilization, Achilles Tendon
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,
Iliotibial Band Tenodesis,
Patellar Ligament and Tendon
Avulsion Repair. |
| Reason for 510(k) submission: | The purpose of this Special 510(k) is to obtain clearance for the X-Twist
Biocomposite Suture Anchor, as an extension of the Parcus Medical X-Twist
Suture Anchor portfolio, for use in the fixation of soft tissue to bone. | | Knee: Anterior Cruciate
Ligament Repair, Medial
Collateral Ligament Repair,
Lateral Collateral Ligament
Repair, Patellar Tendon
Repair, Posterior Oblique
Ligament Repair, Iliotibial
Band Tenodesis, Quadriceps
Tendon Repair, Meniscal
Root Repair, Secondary or
adjunct fixation for ACL/PCL
reconstruction or repair,
MPFL Repair/Reconstruction | 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. |
| Device Description: | The X-Twist Biocomposite Suture Anchor consists of the implants (anchor
and anchor tip) and the anchor driver assembly. The anchor and anchor tip
are provided assembled to the driver and sterile. The X-Twist Biocomposite
anchor is molded using a composite of $ β $ TCP (beta-tricalcium-phosphate)
and PLGA (poly-lactic-co-glycolic acid). The anchor tip is molded using PEEK
(polyetheretherketone). The anchor is fully threaded, double-helical,
cannulated, and has inline fenestrations on each quarter-turn face. The
anchor tip is retained on the driver via retention suture(s) or suture tape(s)
that are passed through the driver cannulation, looped over the retention
bridge within the tip, and returned out the proximal end of the driver handle | | Elbow: Ulnar/Radial
Collateral Ligament
Reconstruction, Lateral | Elbow: Tennis Elbow Repair,
Biceps Tendon Reattachment. | Elbow: Tennis Elbow Repair,
Biceps Tendon Reattachment. |
| | | Hand/Wrist: Scapholunate
Ligament Reconstruction, Ulnar | Hand/Wrist: Scapholunate
Ligament Reconstruction, Ulnar | | |
4
and cleated. These devices are to be used with a drill, awl, and/or bone tap. The X-Twist Biocomposite Suture Anchors are provided sterile and in 4.75mm, 5.5mm, or 6.25mm diameters.
Device Characteristics
5
| | Epicondylitis Repair | or Radial Collateral Ligament
Reconstruction, TFCC. | or Radial Collateral Ligament
Reconstruction, TFCC. |
|------------------|-----------------------------------|--------------------------------------------------------|--------------------------------------------------------|
| Implant Material | B-TCP/PLGA
LT1- PEEK
UHMWPE | LT1- PEEK
UHMWPE | B-TCP/PLGA
UHMWPE |
| Single use only | Yes | Yes | Yes |
| Sterility | Sterile, EO | Sterile, EO | Sterile, EO |
| Shelf-life | 5-years | 5-years | 5-years |
Non-clinical Testing
The non-clinical testing was conducted to evaluate the biocompatibility and performance of the subject device. The testing was performed using the same methods and protocols as that used for the predicate devices. The results of the testing were assessed against the results obtained with the predicate devices to determine substantial equivalency for design, performance, and safety.
Final devices were subjected to bacterial endotoxin testing in accordance with USP and USP .
| Test | Test Article | Negative
Control | Standard
Curve | PPC | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Evaluation of
the USP
Limulus
Amebocyte
Lysate (LAL)
Test - Kinetic-
Turbidimetric
Method - as
an End-
Product
Endotoxin
Test | Ten (10)
disassembled
devices, each
submerged in
100ml LAL
reagent water
(LRW),
extracted in a
shaker
incubator at
37°C for one
(1) hour | Sterile
LRW | Control
Standard
Endotoxin
(CSE) at
10, 1.0,
0.1, 0.01
EU/ml | Test
article
spiked
with 0.1
EU/ml | Standard Curve
Correlation
Coefficient:
≥0.98
Slope of curve
between -0.400
and -0.100.
PPC: 50-200%
Test Article
Endotoxin
Concentration:
≤20 EU/device | Standard
Curve
Correlation
Coefficient:
1.00
Slope: -0.213
PPC: 173%
Test Article
Endotoxin
Concentration: