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 Avulsion 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.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: X-Twist PEEK Suture Anchor

Type of Study: Non-clinical (benchtop) testing and bacterial endotoxin testing. No clinical study was performed.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Benchtop Testing	Met defined acceptance criteria, demonstrated substantial equivalency for design and performance when assessed against 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. (Specific numerical values not provided in the summary)
- Cycle loading and elongation	Not explicitly defined in this section, but implied to be comparable to predicate.	Met defined acceptance criteria.
- Insertion torque	Not explicitly defined in this section, but implied to be comparable to predicate.	Met defined acceptance criteria.
- Anchor pullout force	Not explicitly defined in this section, but implied to be comparable to predicate.	Met defined acceptance criteria.
Bacterial Endotoxin Testing (USP <85>)	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: <1 EU/device

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

Benchtop Testing: The sample size for benchtop tests (cycle loading, elongation, insertion torque, pullout force) is not specified in the provided summary.
Bacterial Endotoxin Testing:
- Sample Size: Ten (10) disassembled devices were used as test articles.
- Data Provenance: The origin of the devices or components is not stated. This is laboratory-based, non-clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This study is a non-clinical, benchtop and laboratory testing evaluation for mechanical performance and bacterial endotoxin levels. It does not involve expert interpretation or ground truth establishment in the traditional sense of clinical or diagnostic studies. The "ground truth" for these tests is based on established engineering principles and medical device standards (e.g., USP <85> and <161>).

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical benchtop and laboratory testing, there is no adjudication method involving human interpretation to establish ground truth for a test set. The results are quantitative measurements against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

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

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant (suture anchor), not an algorithm or AI-powered system, so the concept of "standalone performance" in the context of AI does not apply. The performance evaluated is the physical and biological characteristics of the device itself.

7. Type of Ground Truth Used

Benchtop Testing: Engineering performance metrics (e.g., force, torque, elongation) compared against established design specifications and predicate device performance.
Bacterial Endotoxin Testing: Quantitative measurement of endotoxin levels against a regulatory standard (USP <85> and <161>).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms. While the device's design might have involved iterative testing and refinement, this is not documented as a formal "training set" in the context of this submission. The "training" in a broad sense would be the development process and previous predicate device data.

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

Not applicable. As no formal "training set" (in the AI/ML sense) was used, this question is not relevant. The "ground truth" for the device's development would likely be established through biomechanical principles, material science, and the performance characteristics of previously cleared predicate devices.

Summary

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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

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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

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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.

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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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 34243USA
Official Correspondent:	Calen Souther, MSSenior Specialist, Regulatory AffairsPhone: (770) 616-1389Email: 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, 2017Parcus 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 PEEKSuture Anchor, as an extension of the Parcus suture anchor portfolio, foruse in the fixation of soft tissue to bone.
Description of Device:	The X-Twist PEEK Suture Anchor consists of an implantable anchor andanchor tip that are provided assembled to a driver. Retention suture(s) orsuture tapes(s) are preloaded through the driver cannulation to secure theanchor tip onto the driver shaft. The anchor tip can be loaded withadditional suture(s) or suture tapes(s) if needed for the intended surgicalprocedure. Clockwise rotation of the driver allows for advancement of thefully threaded anchor and anchor tip into the prepared bone socket to serveas the point of fixation for soft tissue repair.

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Device Characteristics

	X-Twist PEEK Suture Anchor	Parcus Slik AnchorParcus Twist PEEK Suture Anchor
510(k)clearance	Subject Device	K170327 K120942
Manufacturer	Parcus Medical	Parcus Medical
Common Name	Fastener, Fixation, Non-degradable, softtissue	Fastener, Fixation, Non-degradable, soft tissue
Regulation	21 CFR 888.3040	21 CFR 888.3040
Class Name	Smooth or threaded metallic bone fixationfastener	Smooth or threaded metallic bone fixationfastener
Class	Class II	Class II
Product Code	MBI	MBI
Indication for Use	The X-Twist PEEK Suture Anchors areindicated for attachment of soft tissue tobone. These products are intended for thefollowing indications:	The Parcus Slik Anchors and Twist PEEK SutureAnchors are indicated for attachment of softtissue to bone. These products are intended forthe following indications:
	Shoulder: Rotator Cuff Repair,Acromioclavicular Separation Repair, BankartLesion Repair, Biceps Tenodesis, CapsularShift or Capsulolabral Reconstruction, DeltoidRepair, SLAP Lesion Repair.	Shoulder: Rotator Cuff Repair, AcromioclavicularSeparation Repair, Bankart Lesion Repair, BicepsTenodesis, Capsular Shift or CapsulolabralReconstruction, Deltoid Repair, SLAP LesionRepair.
	Knee: Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, PosteriorOblique Ligament Repair, Extra CapsularReconstruction, Iliotibial Band Tenodesis,Patellar Ligament and Tendon AvulsionRepair.	Knee: Medial Collateral Ligament Repair, LateralCollateral Ligament Repair, Posterior ObliqueLigament Repair, Extra Capsular Reconstruction,lliotibial Band Tenodesis, Patellar Ligament andTendon Avulsion Repair.
	Foot/Ankle: Lateral Stabilization, MedialStabilization, Midfoot Reconstruction, AchillesTendon Repair, Hallux Valgus Reconstruction,Metatarsal Ligament Repair.	Foot/Ankle: Lateral Stabilization, MedialStabilization, Midfoot Reconstruction, AchillesTendon Repair, Hallux Valgus Reconstruction,Metatarsal Ligament Repair.
	Elbow: Tennis Elbow Repair, Biceps TendonReattachment.	Elbow: Tennis Elbow Repair, Biceps TendonReattachment.
	Hand/Wrist: Scapholunate LigamentReconstruction, Ulnar or Radial CollateralLigament Reconstruction, TFCC.	Hand/Wrist: Scapholunate LigamentReconstruction, Ulnar or Radial CollateralLigament Reconstruction, TFCC.
Implant Material	LT1- PEEKUHMWPE	LT1- PEEKUHMWPE
Single use only	Yes	Yes
Sterility	Sterile, EO	Sterile, EO
Shelf-life	5-years	5-years

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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 <85>.

Test	Test Article	NegativeControl	StandardCurve	PPC	AcceptanceCriteria	Results
USP <85> and<161>Inhibition/EnhancementSingle LotValidation forthe KineticTurbidimetricLimulusAmebocyteLysate (LAL)Test	Ten (10)disassembleddevices, eachsubmerged in1000ml LALreagent water(LRW),extracted atroomtemperaturefor one (1)hour	SterileLRW	ControlStandardEndotoxin(CSE) at1.23,0.25,0.05, 0.01EU/ml	Testarticlespikedwith0.05EU/ml	StandardCurveCorrelationCoefficient:≥0.98Neg. ControlOnset Time:Onset time >lowest CalStandardPPC: 50-200%Test ArticleEndotoxinConcentration:≤20 EU/device	Standard CurveCorrelationCoefficient:1.00Neg. ControlOnset Time:>6000 secondsPPC: 58%Test ArticleEndotoxinConcentration:<1 EU/device

The results of the bacterial endotoxin test met the requirements of the FDA-recognized standards USP <85> and USP <161>.

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.

Regulation Number and Section

§ 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.