The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures:

Shoulder: Rotator Cuff 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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty).
Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction.
Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair.

Device Description

The STATIV® Knotted UHMWPE Suture Anchor is a fixation device intended to provide secure fixation of soft tissue to bone and is available in self-tap/self-punching variant also. It consists of a soft Suture Anchor with attached non-absorbable suture(s) to an inserter with handle. The Anchor are available in various sizes, preloaded with suture, tape or suture-tape combinations. This device is provided sterile, for single use only.

AI/ML Overview

The provided text is a 510(k) Summary for the STATIV® Knotted UHMWPE Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance data.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the subject device. Instead, it states:

"The pull-out strength and displacement under cyclic loading of STATIV® Knotted UHMWPE Suture Anchor and Predicate device. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the STATIV® Knotted UHMWPE Suture Anchor and the predicate device."
"During the bench testing of subject device, it was observed that the changes in dimensions are not leading to any kind of new risks with the performance of subject device, and the acceptance criteria was met in each of the performance tests as per defined guidelines and applicable standards." (Emphasis added)

While it indicates that acceptance criteria were met, the specific numerical values for these criteria and the measured performance of the STATIV® Knotted UHMWPE Suture Anchor are not detailed in this summary. It only broadly mentions "Pull out Strength" and "Cyclical Loading" as performance data.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "bench testing" and "literature study."

For the direct performance testing of the subject device (Pull out Strength and Cyclic Loading), the sample size is not specified.
The provenance of this data (e.g., conducted by Healthium Medtech Limited in India) is not explicitly stated, although the manufacturer is based in Bangalore, India.
The nature of the study (retrospective or prospective) is also not specified, but given it's bench testing for a new device, it would typically be considered prospective.

For "SE Analysis 1: Anchor Material," a "literature study" is referenced: "The influence of suture material on the strength of horizontal mattress suture configuration for meniscus repair." Reference 1 points to https://pubmed.ncbi.nlm.nih.gov/23340094/. The details of this secondary study's sample size and provenance would be found in the linked publication, but are not present in this FDA document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable to the provided document. The device is a physical suture anchor, and the evaluation involves bench testing of mechanical properties, not interpretation of data by experts for ground truth establishment in the way it would be for a diagnostic AI device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable as the evaluation relies on physical bench testing rather than subjective human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a surgical implant (suture anchor), not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a surgical implant (suture anchor), not an algorithm. Performance testing was done on the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench performance data (pull-out strength and cyclic loading), the "ground truth" would be established by standardized mechanical testing procedures and measurements using calibrated equipment, as per "defined guidelines and applicable standards." These are objective, quantitative measurements, not expert consensus or pathology in the context of diagnostic devices.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable. As stated above, the device is not an AI model.

Summary

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March 22, 2023

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Healthium Medtech Limited Pankaj Dawar Deputy General Manager Regulatory Affairs 472-D. 13th Cross, 4th Phase, Peenya Industrial Area Bangalore. Karnataka 560058 India

Re: K223889

Trade/Device Name: Stativ® Knotted UHMWPE 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: December 23, 2022 Received: December 27, 2022

Dear Pankaj Dawar:

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

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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 (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.

Sara S. Thompson -S

For

Laurence D. Coyne. Ph.D. 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) K223889

Device Name STATIV® Knotted UHMWPE Suture Anchor

Indications for Use (Describe)

The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures:

Shoulder: Rotator Cuff 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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty).
Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction.
Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon 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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Image /page/3/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is in large, bold, black letters, with the "O" in "Sironix" being a red circle. Below "Sironix" is the phrase "Arthroscopy Solutions" in smaller, black letters.

Image /page/3/Picture/2 description: The image contains the text "K223889" at the top left. To the right of the text is a logo with an orange circle overlapping a blue circle with a white cross in the middle. Below the text and logo is the word "Healthium" in a blue, sans-serif font.

1. 510(k) Summary

1.1. Submitter Information:

Application Correspondent:	PANKAJ DAWARHealthium Medtech Limited472-D, 13th Cross, 4th Phase,Peenya Industrial Area,Bangalore, Karnataka, 560058, INDIA.
Phone:	+91-9886529934
E-mail:	pankaj.d@healthiummedtech.com
Specification Developer:	Healthium Medtech Limited472-D, 13th Cross, 4th Phase,Peenya Industrial Area,Bangalore, Karnataka, 560058, INDIA.
Contact Person:	PANKAJ DAWAR
Phone:	+ 91-80-41868000
E-mail:	pankaj.d@healthiummedtech.com
Date Prepared:	20-03-2023

1.2. Device Identification:

Device Trade Name:	STATIV® Knotted UHMWPE Suture Anchor
Device Common Name:	Non-Absorbable Suture Anchor
Classification Name:	Smooth or threaded metallic bone fixation fastener
Device Class:	Class II
Regulation Number:	21 CFR 888.3040
Product Code:	MBI

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Image /page/4/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller font.

Image /page/4/Picture/2 description: The image contains the text "K223889" in a bold, sans-serif font. Below the text is the word "Healthium" in a larger, bold, sans-serif font. To the right of the text is a logo consisting of an orange circle overlapping a blue circle, with a white cross shape where they intersect.

1.3. Predicate Devices:

Device Name	510(k) Number
Arthrex FiberTak Suture Anchor (Primary)	K203268
Fixone All Suture Anchor (Secondary)	K192709

Device Description 1.4.

Materials Specifications

1. Anchor :
- Loop: Non-absorbable, UHMWPE USP #3, USP #7
- A Suture : Non-absorbable, UHMWPE USP #2
- A Tape : Non-absorbable UHMWPE 1.5mm Round-Flat-Round
- A Additive: Polycaprolactone (Average Mn 80,000)
1. Dispenser : Stainless Steel (SS 300 Series)
1. Handle : ABS (Acrylonitrile Butadiene Styrene)
Ring : Silicone Rubber Ring 4.

Intended Use & Indications for Use 1.5.

Intended Use

STATIV® Knotted UHMWPE Suture Anchor with the sutures/tapes are Intended for soft tissue fixation to the bone. These sutures/tapes may be incorporated, as components, into surgeries where constructs including those with allograft or auto graft tissues are used for repair.

Indications for Use

The STATIV® Knotted UHMWPE Suture Anchor is indicated for the fixation, by use of sutures, of soft tissue to bone in the following surgical procedures:

1. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
1. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Midfoot reconstruction.

Healthium Medtech Limited
Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India	Page 2 of 7
www.healthiummedtech.com CIN : U03311KA1992PLC013831

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Image /page/5/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is written in a bold, sans-serif font, with the "O" in "Sironix" replaced by a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/5/Picture/2 description: The image contains the text "K223889" at the top, followed by the word "Healthium" in a stylized font. To the right of the text is a logo consisting of a blue circle intersected by a white cross, with an orange circle partially overlapping the blue one. The logo is simple and modern, complementing the text.

1. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
1. Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty).
1. Elbow: Biceps tendon reattachment, Ulnar or Radial collateral ligament reconstruction.
1. Hip: Acetabular labral repair, Capsular repair, Gluteal Tendon Repair.

1.6. Comparison of Technological Characteristics

The fundamental scientific technology, materials of construction and mechanism of operation are similar between the subject device STATIV® Knotted UHMWPE Suture Anchor and the predicate device.

Table 2 summarizes the comparison of technological characteristics between the subject and predicate device.

S. No	Parameters	Arthrex FiberTak SutureAnchor (K203268)	STATIV® KnottedUHMWPE Suture Anchor(Subject device)	Comments
1.	Manufacturer	Arthrex Inc.	Healthium Medtech Limited	-
2.	Product Code	MBI	MBI	Similar
3.	RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	Similar
4.	Classification	Class II	Class II	Similar
5.	Intended Use	The Arthrex FiberTak SutureAnchor is intended forfixation of suture (soft tissue)to bone in the shoulder,foot/ankle, knee, hand/wrist,elbow, and hip in thefollowing procedures:Elbow: Biceps TendonReattachment, Ulnar orRadial Collateral LigamentReconstructionShoulder: Rotator CuffRepair, Bankart Repair, SLAPLesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair,	The STATIV® KnottedUHMWPE Suture Anchor isindicated for the fixation, byuse of sutures, of soft tissue tobone in the following surgicalprocedures:1. Shoulder: Rotator CuffRepair, Bankart Repair,SLAP Lesion Repair,Biceps Tenodesis,Acromio-ClavicularSeparation Repair, DeltoidRepair, Capsular Shift orCapsulolabralReconstruction.2. Foot/Ankle: LateralStabilization, Medial	Similar

Table 2: Substantial Equivalence Table

Healthium Medtech Limited
Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, Indiawww.healthiummedtech.com CIN : U03311KA1992PLC013831	Page 3 of 7

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Image /page/6/Picture/0 description: The image shows the logo for Sironix. The logo is black, except for the "O" in Sironix, which is red. Below the company name is the text "Arthroscopy Solutions".

Image /page/6/Picture/2 description: The image contains the text "K223889" in a bold, sans-serif font at the top. Below the text is the word "Healthium" in a stylized font, with the "H" being larger than the other letters. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape in the center where they overlap.

S.No	Parameters	Arthrex FiberTak SutureAnchor (K203268)	STATIV® KnottedUHMWPE Suture Anchor(Subject device)	Comments
		Deltoid Repair, Capsular Shiftor CapsulolabralReconstructionHand/Wrist: ScapholunateLigament Reconstruction,Repair/Reconstruction ofcollateral ligaments, Repair ofFlexor and Extensor Tendonsat the PIP, DIP and MCPjoints for all digits, digitaltendon transfers, CarpalLigament Reconstruction andCarpometacarpal jointarthroplasty (basal thumbjoint arthroplasty)Foot/Ankle: LateralStabilization, MedialStabilization, Achilles TendonRepair, Metatarsal LigamentRepair, Hallux Valgusreconstruction, digital tendontransfers, Mid-footreconstructionKnee: Medial CollateralLigament Repair, LateralCollateral Ligament Repair,Patellar Tendon Repair,Posterior Oblique LigamentRepair, Iliotibial BandTenodesis, Joint CapsuleClosureHip: Capsular repair,Acetabular labral repair,Gluteal Tendon Repair.	Stabilization, AchillesTendon Repair, MetatarsalLigament Repair, HalluxValgus reconstruction,digital tendon transfers,Mid-foot reconstruction.3. Knee: Medial CollateralLigament Repair, LateralCollateral LigamentRepair, Patellar TendonRepair, Posterior ObliqueLigament Repair, IliotibialBand Tenodesis, JointCapsule Closure.4. Hand/Wrist: ScapholunateLigament Reconstruction,Repair/Reconstruction ofcollateral ligaments, Repairof Flexor and ExtensorTendons at the PIP, DIPand MCP joints for alldigits, digital tendontransfers, Carpal LigamentReconstruction andCarpometacarpal jointarthroplasty (basal thumbjoint arthroplasty).5. Elbow: Biceps tendonreattachment, Ulnar orRadial collateral ligamentreconstruction.6. Hip: Acetabular labralrepair, Capsular repair,Gluteal Tendon Repair.
6.	Anchor LoopMaterial	Hollow braid of polyester	UHMWPE	SE Analysis 1
7.	Suture&Tape Material	UHWMPE or a polyblend ofUHMWPE and polyester	Suture- UHMWPE USP #2,Tape- UHMWPE 1.5mm flat	Similar
8.	Design	Arthrex Suture Anchor aredesigned to repair soft tissueto bone through a variety ofinnovative anchor styles,materials, and sutureconfigurations. As the next	STATIV® KnottedUHMWPE Suture Anchorconstructed of strong UltraHigh Molecular WeightPolyethylene (UHMWPE)suture material. STATIV®	Similar

Healthium Medtech Limited
Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru - 560058, India Page 4 of 7
www.healthiummedtech.com CIN : U03311KA1992PLC013831

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Image /page/7/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is in bold, with the "O" in "SIRONIX" being a red circle. Underneath "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, less bold font. The logo is simple and professional.

Image /page/7/Picture/2 description: The image contains the text "K223889" in a bold, sans-serif font. Below the text is the word "Healthium" in a stylized, blue font. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape in the center where they intersect.

S.No	Parameters	Arthrex FiberTak SutureAnchor (K203268)	STATIV® KnottedUHMWPE Suture Anchor(Subject device)	Comments
		evolution of knotless rotatorcuff repair, the FiberTakSpeedBridge technique iscompleted with FiberTak softAnchor on the medial row andFiberTape® sutures fixatedlaterally with trustedSwiveLock® Anchor. Thisknotless repair creates aquick, secure construct in asfew as three suture passingsteps.	Knotted UHMWPE SutureAnchor is the Suture Anchorwith sutures(s)/tape(s)combination. It assuredcentralized deployment of theanchor into pilot hole. Postdeployment, the unique tri-pod bunched up patterndoubles its size, which givesmuch higher pull out strength.
9.	SpecificationsandDimensions	FiberTak Suture Anchor with #2FiberWire CL (White/Blue) --AR-3600FiberTak Suture Anchor, doubleloaded with two #2 FiberWireCL (White/Blue, White/Black),-AR-3600-2FiberTak with 1.3 mmSutureTape (White/Blue), - AR-3602FiberTak Suture Anchor, DoubleLoaded with two 1.3 mmSutureTape (White/Blue,White/Black),- AR-3602-2FiberTak with #2 TigerTail(Blue/Black) -AR-3603FiberTak Suture Anchor, DoubleLoaded with two #2 TigerTail(Blue/Black and White/Black)-AR-3603-22.6 FiberTak Soft Anchor,Double Loaded with two #2FiberWire CL (Blue/White,Black/White) -AR-3630-12.6 FiberTak Soft Anchor, TripleLoaded with three #2 FiberWireCL (Blue/White, Black/White,White)- AR-3631-12.6 FiberTak Soft Anchor,Double Loaded with two 1.3 mm	1.5mm Single Suture1.8mm Single Suture1.5mm Single Tape1.8mm Single Tape1.8mm Double Sutures1.8mm Double Tapes2.5 mm Double Sutures (Self-Tap)2.5 mm Double Tapes (Self-Tap)2.5 mm Triple Sutures (Self-Tap)2.9 mm Double Sutures (Self-Tap)2.9 mm Double Tapes (Self-Tap)2.9 mm Triple Sutures (Self-Tap)	SE Analysis 2

Healthium Medtech Limited
Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, Indiawww.healthiummedtech.com CIN : U03311KA1992PLC013831	Page 5 of 7

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Image /page/8/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below "SIRONIX" is the text "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/8/Picture/2 description: The image contains the text "K223889" in black font at the top left. Below the text is the word "Healthium" in a blue, stylized font. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue.

S.No	Parameters	Arthrex FiberTak SutureAnchor (K203268)	STATIV® KnottedUHMWPE Suture Anchor(Subject device)	Comments
		SutureTape (White/Blue andWhite/Black) - AR-3632
		2.6 FiberTak Soft Anchor, TripleLoaded with three 1.3 mmSutureTape (White/Blue,White/Black and White)- AR-3633
10.	SingleUse/Reuse	Single Use	Single Use	Similar
11.	Shelf Life	5 years	5 Years	Similar
12.	Sterilization	Provided in Sterile conditions(EO Sterilization).	Provided in Sterile conditions(EO Sterilization).	Similar
13.	PerformanceData	Cyclic pull-out test,Bacterial Endotoxin	Bench Performance:Pull out StrengthCyclical LoadingBacterial Endotoxin	Similar
14.	Safety Data	No Data Available	Biocompatibility:Skin Sensitization,Intracutaneous reactivity,Material MediatedPyrogenicity,Acute Systemic Toxicity,In vitro cytotoxicity.	-

SE Analysis 1:

Anchor Material:

Difference in Anchor Material does not affect the safety and efficacy of subject device based on the reference comparative study. Predicate device (K203268) has an anchor loop made up of Hollow braid of polyester, whereas the subject device has an anchor made up of UHMWPE.

From the literature study4 it can be inferred that the Polyester suture had lower ultimate load than all groups of sutures used in the study except the suture composed of polyester and UHMWPE (P<.05). Pure UHMWPE suture had higher ultimate failure load than sutures composed of either polyester or polyester plus UHMWPE (P<.05). Predominant failure mode was suture cutting through the meniscus for the groups except for polyester suture which failed by suture rupture.

This literature study shows that UHMWPE material has better ultimate load than the material used in predicate and this change is not raising any questions on the safety and efficacy of the subject device.

Healthium Medtech Limited
Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, Indiawww.healthiummedtech.com CIN : U03311KA1992PLC013831	Page 6 of 7

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Image /page/9/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller font.

Image /page/9/Picture/2 description: The image contains the alphanumeric string "K223889" in black font. Below this string is the word "Healthium" in a bold, blue font. To the right of the word "Healthium" is a logo consisting of a blue circle and an orange circle, with a white cross shape overlaying them.

Reference 1: The influence of suture material on the strength of horizontal mattress suture configuration for meniscus repair.

1 https://pubmed.ncbi.nlm.nih.gov/23340094/

SE Analysis 2:

Specification and Dimensions:

During the bench testing of subject device, it was observed that the changes in dimensions are not leading to any kind of new risks with the performance of subject device, and the acceptance criteria was met in each of the performance tests as per defined guidelines and applicable standards. By considering the performance data of the subject device, it is evident that the changes in dimensions are not causing and or does not affect the safety and efficacy of the product when comparing it with Predicate device. The different sizes of the subject device are determined through the diameter of the dispenser which is not implantable in nature, however, there is no change in the size of the implant, so the variation in sizes of the dispenser will not lead to any kind of new risks related to safety and performance.

1.7. Summary of Performance Data

The pull-out strength and displacement under cyclic loading of STATIV® Knotted UHMWPE Suture Anchor and Predicate device. The results were reviewed and side by side comparisons were done with the identified predicate device and it demonstrated that there were no significant differences between the STATIV® Knotted UHMWPE Suture Anchor and the predicate device.

1.8. Clinical Testing

Not Applicable

1.9. Conclusion

There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device (Arthrex FiberTak Suture Anchor) in design, Intended use, Indications for use, function, Sterilization method, Shelf Life, and operational principles. From the data available we can justify that the STATIV® Knotted UHMWPE Suture Anchor is as safe, and as effective and performs the same indications for use as that of already marketed predicate device identified in 1.3 of 510(k) summary.

Healthium Medtech Limited
Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India
www.healthiummedtech.com CIN : U03311KA1992PLC013831	Page 7 of 7

Regulation Number and Section

N/A