Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly describe a physical suture anchor and its application in surgical procedures, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are bench tests of mechanical properties.

Therapeutic

No
The device is a fixation device for soft tissue to bone, not a device that treats a disease or condition.

Diagnostic

No
The device, a suture anchor, is used for fixing soft tissue to bone in surgical procedures, making it a therapeutic or fixation device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "fixation device" consisting of a "soft Suture Anchor with attached non-absorbable suture(s) to an inserter with handle." This describes a physical, implantable medical device, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as being used for the fixation of soft tissue to bone during surgical procedures. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as a "fixation device" consisting of a suture anchor and attached sutures. This is a physical implant used to hold tissues together.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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:

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.

Product codes (comma separated list FDA assigned to the subject device)

MBI

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow, Hip

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)

Bench Performance:
Pull out Strength
Cyclical Loading
Bacterial Endotoxin

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.

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.

K203268, K192709

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.

Not Found

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

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.

Summary

0

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

1

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

2

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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3

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 DAWAR
Healthium Medtech Limited
472-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 Limited
472-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

4

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.

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.

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

5

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 Suture
Anchor (K203268) | STATIV® Knotted
UHMWPE Suture Anchor
(Subject device) | Comments |
|-------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| 1. | Manufacturer | Arthrex Inc. | Healthium Medtech Limited | - |
| 2. | Product Code | MBI | MBI | Similar |
| 3. | Regulation
Number | 21 CFR 888.3040 | 21 CFR 888.3040 | Similar |
| 4. | Classification | Class II | Class II | Similar |
| 5. | Intended Use | The Arthrex FiberTak Suture
Anchor is intended for
fixation of suture (soft tissue)
to bone in the shoulder,
foot/ankle, knee, hand/wrist,
elbow, and hip in the
following procedures:
Elbow: Biceps Tendon
Reattachment, Ulnar or
Radial Collateral Ligament
Reconstruction
Shoulder: Rotator Cuff
Repair, Bankart Repair, SLAP
Lesion Repair, Biceps
Tenodesis, Acromio-
Clavicular Separation Repair, | 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, Bankart Repair,
SLAP Lesion Repair,
Biceps Tenodesis,
Acromio-Clavicular
Separation Repair, Deltoid
Repair, Capsular Shift or
Capsulolabral
Reconstruction.
Foot/Ankle: Lateral
Stabilization, Medial | Similar |

Table 2: Substantial Equivalence Table

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

6

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 Suture
Anchor (K203268) | STATIV® Knotted
UHMWPE Suture Anchor
(Subject device) | Comments |
|----------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| | | Deltoid Repair, Capsular Shift
or Capsulolabral
Reconstruction
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)
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
Hip: Capsular repair,
Acetabular labral repair,
Gluteal Tendon Repair. | Stabilization, Achilles
Tendon Repair, Metatarsal
Ligament Repair, Hallux
Valgus reconstruction,
digital tendon transfers,
Mid-foot reconstruction.
3. Knee: Medial Collateral
Ligament Repair, Lateral
Collateral Ligament
Repair, Patellar Tendon
Repair, Posterior Oblique
Ligament Repair, Iliotibial
Band Tenodesis, Joint
Capsule Closure.
4. 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).
5. Elbow: Biceps tendon
reattachment, Ulnar or
Radial collateral ligament
reconstruction.
6. Hip: Acetabular labral
repair, Capsular repair,
Gluteal Tendon Repair. | |
| 6. | Anchor Loop
Material | Hollow braid of polyester | UHMWPE | SE Analysis 1 |
| 7. | Suture
&
Tape Material | UHWMPE or a polyblend of
UHMWPE and polyester | Suture- UHMWPE USP #2,
Tape- UHMWPE 1.5mm flat | Similar |
| 8. | Design | Arthrex Suture Anchor are
designed to repair soft tissue
to bone through a variety of
innovative anchor styles,
materials, and suture
configurations. As the next | STATIV® Knotted
UHMWPE Suture Anchor
constructed of strong Ultra
High Molecular Weight
Polyethylene (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

7

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 Suture
Anchor (K203268) | STATIV® Knotted
UHMWPE Suture Anchor
(Subject device) | Comments |
|----------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| | | evolution of knotless rotator
cuff repair, the FiberTak
SpeedBridge technique is
completed with FiberTak soft
Anchor on the medial row and
FiberTape® sutures fixated
laterally with trusted
SwiveLock® Anchor. This
knotless repair creates a
quick, secure construct in as
few as three suture passing
steps. | Knotted UHMWPE Suture
Anchor is the Suture Anchor
with sutures(s)/tape(s)
combination. It assured
centralized deployment of the
anchor into pilot hole. Post
deployment, the unique tri-
pod bunched up pattern
doubles its size, which gives
much higher pull out strength. | |
| 9. | Specifications
and
Dimensions | FiberTak Suture Anchor with #2
FiberWire CL (White/Blue) --
AR-3600
FiberTak Suture Anchor, double
loaded with two #2 FiberWire
CL (White/Blue, White/Black),-
AR-3600-2
FiberTak with 1.3 mm
SutureTape (White/Blue), - AR-
3602
FiberTak Suture Anchor, Double
Loaded with two 1.3 mm
SutureTape (White/Blue,
White/Black),- AR-3602-2
FiberTak with #2 TigerTail
(Blue/Black) -AR-3603
FiberTak Suture Anchor, Double
Loaded with two #2 TigerTail
(Blue/Black and White/Black)-
AR-3603-2
2.6 FiberTak Soft Anchor,
Double Loaded with two #2
FiberWire CL (Blue/White,
Black/White) -AR-3630-1
2.6 FiberTak Soft Anchor, Triple
Loaded with three #2 FiberWire
CL (Blue/White, Black/White,
White)- AR-3631-1
2.6 FiberTak Soft Anchor,
Double Loaded with two 1.3 mm | 1.5mm Single Suture
1.8mm Single Suture
1.5mm Single Tape
1.8mm Single Tape
1.8mm Double Sutures
1.8mm Double Tapes
2.5 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, India
www.healthiummedtech.com CIN : U03311KA1992PLC013831	Page 5 of 7

8

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 Suture
Anchor (K203268) | STATIV® Knotted
UHMWPE Suture Anchor
(Subject device) | Comments |
|----------|---------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | | SutureTape (White/Blue and
White/Black) - AR-3632 | | |
| | | 2.6 FiberTak Soft Anchor, Triple
Loaded with three 1.3 mm
SutureTape (White/Blue,
White/Black and White)- AR-
3633 | | |
| 10. | Single
Use/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. | Performance
Data | Cyclic pull-out test,
Bacterial Endotoxin | Bench Performance:
Pull out Strength
Cyclical Loading
Bacterial Endotoxin | Similar |
| 14. | Safety Data | No Data Available | Biocompatibility:
Skin Sensitization,
Intracutaneous reactivity,
Material Mediated
Pyrogenicity,
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