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

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.

AI/ML Overview

The X-Twist Biocomposite Suture Anchor, as described in this 510(k) summary, did not undergo a study to prove acceptance criteria in the traditional sense of a clinical or standalone performance study. Instead, the FDA determined substantial equivalence based on non-clinical testing and comparison to predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For the specific non-clinical test reported, here are the acceptance criteria and results:

Test	Acceptance Criteria	Results
Evaluation of the USP Limulus Amebocyte Lysate (LAL) Test - Kinetic-Turbidimetric Method - as an End-Product Endotoxin Test	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: <1.0 EU/device

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Endotoxin Test: Ten (10) disassembled devices were used.
Data Provenance: Not specified, but generally, non-clinical tests performed for FDA submissions are conducted by the manufacturer or a contracted lab. This is a non-clinical, in-vitro test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. For this type of non-clinical endotoxin test, ground truth is established by scientific standards and analytical methods, not human experts.

4. Adjudication Method for the Test Set

Not applicable. This was a laboratory test with quantitative results measured against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a physical medical implant (suture anchor), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

For the reported LAL endotoxin test, the ground truth is established by the analytical measurement against a defined standard, specifically the USP (United States Pharmacopeia) guidelines for Limulus Amebocyte Lysate (LAL) testing, with a Control Standard Endotoxin (CSE) curve.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI model, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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

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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

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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

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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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 SutureAnchor	X-Twist PEEK Suture Anchor	Twist AP (Biocomposite) SutureAnchor
Applicant:	Parcus Medical, LLC.6423 Parkland Dr.Sarasota, FL 34243USA	510(k)clearance	Subject Device	K221135	K183501
Official Correspondent:	Calen Souther, MSManager, Regulatory AffairsPhone: (781) 457-9541Email: 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 andaccessories	Class Name	Single/multiple componentmetallic bone fixationappliances and accessories	Smooth or threaded metallicbone fixation fastener	Single/multiple componentmetallic bone fixation appliancesand 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 BiocompositeSuture Anchors are indicatedfor attachment of soft tissueto bone. These products areintended for the followingindications:	The X-Twist PEEK Suture Anchorsare indicated for attachment ofsoft tissue to bone. Theseproducts are intended for thefollowing indications:	The Parcus Twist AP SutureAnchors are indicated for theattachment of soft tissue tobone. This product is intendedfor the following indications:
Predicate Device Information:	X-Twist PEEK Suture Anchor – K221135 - cleared May 19, 2022Twist AP Suture Anchor - K183501 - cleared March 15, 2019		Shoulder: Rotator CuffRepair, SLAP Lesion Repair,Biceps Tenodesis, Acromio-Clavicular Separation Repair,Deltoid Repair	Shoulder: Rotator Cuff Repair,Acromioclavicular SeparationRepair, Bankart Lesion Repair,Biceps Tenodesis, Capsular Shiftor Capsulolabral Reconstruction,Deltoid Repair, SLAP LesionRepair.	Shoulder: Rotator Cuff Repair,Acromioclavicular SeparationRepair, Bankart Lesion Repair,Biceps Tenodesis, Capsular Shiftor Capsulolabral Reconstruction,Deltoid Repair, SLAP LesionRepair.
Reference Device Information:	Arthrex SwiveLock – K101823 – cleared January 7, 2011		Foot/Ankle: LateralStabilization, MedialStabilization, Achilles TendonRepair	Knee: Medial Collateral LigamentRepair, Lateral CollateralLigament Repair, PosteriorOblique Ligament Repair, ExtraCapsular Reconstruction,Iliotibial Band Tenodesis,Patellar Ligament and TendonAvulsion Repair.	Knee: Medial Collateral LigamentRepair, Lateral CollateralLigament Repair, PosteriorOblique Ligament Repair, ExtraCapsular Reconstruction,Iliotibial Band Tenodesis,Patellar Ligament and TendonAvulsion Repair.
Reason for 510(k) submission:	The purpose of this Special 510(k) is to obtain clearance for the X-TwistBiocomposite Suture Anchor, as an extension of the Parcus Medical X-TwistSuture Anchor portfolio, for use in the fixation of soft tissue to bone.		Knee: Anterior CruciateLigament Repair, MedialCollateral Ligament Repair,Lateral Collateral LigamentRepair, Patellar TendonRepair, Posterior ObliqueLigament Repair, IliotibialBand Tenodesis, QuadricepsTendon Repair, MeniscalRoot Repair, Secondary oradjunct fixation for ACL/PCLreconstruction or repair,MPFL Repair/Reconstruction	Foot/Ankle: Lateral Stabilization,Medial Stabilization, MidfootReconstruction, Achilles TendonRepair, Hallux ValgusReconstruction, MetatarsalLigament Repair.	Foot/Ankle: Lateral Stabilization,Medial Stabilization, MidfootReconstruction, Achilles TendonRepair, Hallux ValgusReconstruction, MetatarsalLigament Repair.
Device Description:	The X-Twist Biocomposite Suture Anchor consists of the implants (anchorand anchor tip) and the anchor driver assembly. The anchor and anchor tipare provided assembled to the driver and sterile. The X-Twist Biocompositeanchor 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. Theanchor tip is retained on the driver via retention suture(s) or suture tape(s)that are passed through the driver cannulation, looped over the retentionbridge within the tip, and returned out the proximal end of the driver handle		Elbow: Ulnar/RadialCollateral LigamentReconstruction, Lateral	Elbow: Tennis Elbow Repair,Biceps Tendon Reattachment.	Elbow: Tennis Elbow Repair,Biceps Tendon Reattachment.
		Hand/Wrist: ScapholunateLigament Reconstruction, Ulnar	Hand/Wrist: ScapholunateLigament Reconstruction, Ulnar

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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

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	Epicondylitis Repair	or Radial Collateral LigamentReconstruction, TFCC.	or Radial Collateral LigamentReconstruction, TFCC.
Implant Material	B-TCP/PLGALT1- PEEKUHMWPE	LT1- PEEKUHMWPE	B-TCP/PLGAUHMWPE
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 <85> and USP <161>.

Test	Test Article	NegativeControl	StandardCurve	PPC	AcceptanceCriteria	Results
Evaluation ofthe USPLimulusAmebocyteLysate (LAL)Test - Kinetic-TurbidimetricMethod - asan End-ProductEndotoxinTest	Ten (10)disassembleddevices, eachsubmerged in100ml LALreagent water(LRW),extracted in ashakerincubator at37°C for one(1) hour	SterileLRW	ControlStandardEndotoxin(CSE) at10, 1.0,0.1, 0.01EU/ml	Testarticlespikedwith 0.1EU/ml	Standard CurveCorrelationCoefficient:≥0.98Slope of curvebetween -0.400and -0.100.PPC: 50-200%Test ArticleEndotoxinConcentration:≤20 EU/device	StandardCurveCorrelationCoefficient:1.00Slope: -0.213PPC: 173%Test ArticleEndotoxinConcentration:<1.0EU/device

Clinical Data

Clinical testing was deemed not necessary for demonstrating substantial equivalence to the predicate devices.

Conclusion

The X-Twist Biocomposite Suture Anchor is substantially equivalent to the predicate devices in which the 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.

Regulation Number and Section

§ 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.